Percutaneous delivery systems for anchoring an implant in a cardiac valve annulus

ABSTRACT

Mitral valve prolapse and mitral regurgitation can be treating by implanting in the mitral annulus a transvalvular intraannular band. The band has a first end, a first anchoring portion located proximate the first end, a second end, a second anchoring portion located proximate the second end, and a central portion. The central portion is positioned so that it extends transversely across a coaptive edge formed by the closure of the mitral valve leaflets. The band may be implanted via translumenal access or via thoracotomy.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. § 119(e) as anonprovisional application of U.S. Prov. App. No. 62/437,898 filed onDec. 22, 2016, U.S. Prov. App. No. 62/491,750 filed Apr. 28, 2017, andU.S. Prov. App. No. 62/549,215 filed Aug. 23, 2017. The disclosure ofeach of the aforementioned priority applications is hereby incorporatedby reference herein in their entireties. This application is alsorelated to U.S. application Ser. No. 15/293111, filed Oct. 13, 2016,which in turn claims the benefit under 35 U.S.C. § 119(e) as anonprovisional application of U.S. Prov. App. No. 62/241,687 filed onOct. 14, 2015. This application is also related to U.S. patentapplication Ser. No. 14/628,114 filed on Feb. 20, 2015, which is in turna continuation of U.S. patent application Ser. No. 13/650,998 filed Oct.12, 2012, now issued as U.S. Pat. No. 8,961,597 on Feb. 24, 2015, whichis a continuation of U.S. patent application Ser. No. 12/579,330 filedOct. 14, 2009, now abandoned, which is a continuation-in-part of U.S.patent application Ser. No. 12/104,011 filed Apr. 16, 2008, and issuedas U.S. Pat. No. 8,262,725 on Sep. 11, 2012. This application is relatedto U.S. Prov. App. No. 62/437898 filed Dec. 22, 2016 and U.S. Prov. App.No. 62/491750 filed Apr. 28, 2017. The disclosure of each of theaforementioned applications is hereby incorporated by reference hereinin their entireties.

BACKGROUND Field of the Invention

Embodiments of the present invention relate generally to treatment ofmitral or tricuspid valve prolapse and mitral regurgitation, and morespecifically, relate to the use of a transvalvular intraannular band totreat mitral valve prolapse and mitral regurgitation.

Description of the Related Art

The heart is a double (left and right side), self-adjusting muscularpump, the parts of which work in unison to propel blood to all parts ofthe body. The right side of the heart receives poorly oxygenated(“venous”) blood from the body from the superior vena cava and inferiorvena cava and pumps it through the pulmonary artery to the lungs foroxygenation. The left side receives well-oxygenated (“arterial”) bloodfrom the lungs through the pulmonary veins and pumps it into the aortafor distribution to the body.

The heart has four chambers, two on each side—the right and left atria,and the right and left ventricles. The atria are the blood-receivingchambers, which pump blood into the ventricles. A wall composed ofmembranous and muscular parts, called the interatrial septum, separatesthe right and left atria. The ventricles are the blood-dischargingchambers. A wall composed of membranous and muscular parts, called theinterventricular septum, separates the right and left ventricles.

The synchronous pumping actions of the left and right sides of the heartconstitute the cardiac cycle. The cycle begins with a period ofventricular relaxation, called ventricular diastole. The cycle ends witha period of ventricular contraction, called ventricular systole.

The heart has four valves that ensure that blood does not flow in thewrong direction during the cardiac cycle; that is, to ensure that theblood does not back flow from the ventricles into the correspondingatria, or back flow from the arteries into the corresponding ventricles.The valve between the left atrium and the left ventricle is the mitralvalve. The valve between the right atrium and the right ventricle is thetricuspid valve. The pulmonary valve is at the opening of the pulmonaryartery. The aortic valve is at the opening of the aorta.

Various disease processes can impair the proper functioning of one ormore of these valves. These include degenerative processes (e.g.,Barlow's Disease, fibroelastic deficiency), inflammatory processes(e.g., Rheumatic Heart Disease) and infectious processes (e.g.,endocarditis). In addition, damage to the ventricle from prior heartattacks (i.e., myocardial infarction secondary to coronary arterydisease) or other heart diseases (e.g., cardiomyopathy) can distort thevalve's geometry causing it to dysfunction.

The mitral valve is comprised of an anterior leaflet and a posteriorleaflet. The bases of the leaflets are fixed to a circumferential partlyfibrous structure, the annulus, preventing dehiscence of the valve. Asubvalvular apparatus of chordae and papillary muscles prevents thevalve from prolapsing into the left atrium. Mitral valve disease can beexpressed as a complex variety of pathological lesions of either valveor subvalvular structures, but can also be related to the functionalstatus of the valve. Functionally the mitral valve disease can becategorized into two anomalies, increased leaflet motion i.e. leafletprolapse leading to regurgitation, or diminished leaflet motion i.e.restricted leaflet motion leading to obstruction and/or regurgitation ofblood flow.

Leaflet prolapse is defined as when a portion of the leaflet overridesthe plane of the orifice during ventricular contraction. The mitralregurgitation can also develop secondary to alteration in the annularventricular apparatus and altered ventricular geometry, followed byincomplete leaflet coaptation. In ischemic heart failure this can beattributed to papillary or lateral wall muscle dysfunction, and innon-ischemic heart failure it can be ascribed to annular dilation andchordal tethering, all as a result of dysfunctional remodeling.

The predominant cause of dysfunction of the mitral valve isregurgitation which produces an ineffective cardiac pump functionresulting in several deleterious conditions such as ventricular andatrial enlargement, pulmonary hypertension and heart-failure andultimately death.

The main objective for the surgical correction is to restore normalfunction and not necessarily anatomical correction. This is accomplishedby replacing the valve or by reconstructing the valve. Both of theprocedures require the use of cardiopulmonary bypass and is a majorsurgical operation carrying a non-negligible early morbidity andmortality risk, and a postoperative rehabilitation for months withsubstantial postoperative pain. Historically, the surgical approach topatients with functional mitral regurgitation was mitral valvereplacement, however with certain adverse consequences such asthromboembolic complications, the need for anticoagulation, insufficientdurability of the valve, loss of ventricular function and geometry.

Reconstruction of the mitral valve is therefore the preferred treatmentfor the correction of mitral valve regurgitation and typically consistsof a quadrangular resection of the posterior valve (valvuloplasty) incombination with a reduction of the mitral valve annulus (annuloplasty)by the means of suturing a ring onto the annulus. These procedures aresurgically demanding and require a bloodless and well-exposed operatingfield for an optimal surgical result. The technique has virtually notbeen changed for more than three decades.

More recently, prolapse of the valve has been repaired by anchoring thefree edge of the prolapsing leaflet to the corresponding free edge ofthe opposing leaflet and thereby restoring apposition but notnecessarily coaptation. In this procedure a ring annuloplasty is alsorequired to attain complete coaptation.

This method commonly referred to as an edge-to-edge or “Alfieri” repairalso has certain drawbacks such as the creation of a double orificevalve and thereby reducing the effective orifice area. Several lessinvasive approaches related to the edge-to-edge technique has beensuggested, for repairing mitral valve regurgitation by placing a clipthrough a catheter to suture the valve edges. However, it still remainsto conduct an annuloplasty procedure, which has not yet been resolved bya catheter technique and therefore is to be performed by conventionalsurgery, which makes the method impractical.

Notwithstanding the presence of a variety of presently availablesurgical techniques and promising catheter based procedures for thefuture, there remains a need for a simple but effective device andcorresponding surgical, minimally invasive or transvascular procedure toreduce mitral valve regurgitation.

SUMMARY OF THE INVENTION

Further features and advantages of the present invention will becomeapparent to those of skill in the art in view of the detaileddescription of preferred embodiments which follows, when consideredtogether with the attached drawings and claims.

Some embodiments of this invention are directed to a transvalvularintraannular band to treat mitral valve prolapse and mitralregurgitation. The terminology “transvalvular” as used hereinencompasses “across”, “over”, or “through” the valve surfaces by anymeans, and “intraannular” provides an axial spatial reference to withinthe native valve annulus or an annular band that serves to functionwithin the valve annulus. Axial with respect to the valve axis meansalong the axis of the valve and can describe position relative to theatrium, “supra”, or relative to the ventricle, “infra”. Specifically, itcreates an axis through which a plane is pierced by the aforementionedaxis, and encompasses an embodiment that is intraannular to addresscoaptation at the valvular plane or series of valvular planes createdduring each cardiac cycle, but does not obviate other salient featuresof the invention that may be clearly infraannular or supraannular duringthe cardiac cycle. Further, the terminology in the followingdescriptions may use “transannular band” or “band” and it means toinclude all features that may be infraannular, intraannular, orsuprannular without or with stating each axially descriptive term. Aswell “offset” refers to directionally displaced from a frame ofreference.

In some embodiments, disclosed herein is a method of delivering atransvalvular intraannular implant. The method includes the steps ofproviding a delivery catheter, the delivery catheter comprising anelongate body; a movable outer sheath; and a transvalvular intraannularimplant having a longitudinal axis and comprising a valve leafletsupport portion and an anchoring portion, the valve leaflet supportportion at least partially longitudinally offset from the anchoringportion; percutaneously delivering the delivery catheter to the vicinityof a heart valve annulus; transforming the implant from a first radiallyreduced configuration to a second radially enlarged configuration; andpositioning the implant in its second radially enlarged configurationwithin the heart valve annulus such that the implant is oriented in thevalve annulus such that the longitudinal axis of the implant is orientedsubstantially transversely to a coaptive edge of a heart valvepositioned within the valve annulus. The heart valve annulus can be, forexample, a mitral, aortic, tricuspid, or pulmonary valve annulus. Insome embodiments, transforming the implant from the first radiallyreduced configuration to the second radially enlarged configurationcomprises retracting or pushing forward the movable outer sheath of thedelivery catheter, exposing the implant. The delivery catheter canfurther include a self-expandable support structure, such as a ring orstent for example, operably connected to the transvalvular implant.Percutaneously delivering the delivery catheter to the vicinity of thevalve annulus can include one or more of approaching the valve annulusfrom a supraannular location, infraannular location, cardiac septum,such as the intra-atrial or intra-ventricular septum, a vascularcut-down, or a thoracoscopic procedure. The anchoring portion of theimplant can be secured to tissue of the valve annulus, such as passing atissue anchor through the anchoring portion of the implant and tissue ofthe valve annulus. In some embodiments, providing a delivery catheterincludes providing a control wire operably attached to the implant, andpositioning the implant includes applying tension to the control wire tomove the implant. The control wire can be detached from the implantafter being properly positioned, in some embodiments.

Also disclosed herein is a transvalvular intraannular delivery system.The system includes a percutaneous delivery catheter comprising anelongate body; a movable outer sheath; and a transvalvular intraannularimplant having a longitudinal axis and comprising a valve leafletsupport portion and an anchoring portion, the valve leaflet supportportion at least partially longitudinally offset from the anchoringportion, wherein the transvalvular implant is configured to betransformable from a first radially reduced configuration to a secondradially enlarged configuration; wherein the transvalvular implant isconfigured to be housed within the percutaneous delivery catheter in itsfirst radially reduced configuration, wherein the transvalvular implantis configured to be positioned in its second radially enlargedconfiguration within a heart valve annulus such that the implant isoriented in the valve annulus such that the longitudinal axis of theimplant is oriented substantially transversely to a coaptive edge of aheart valve positioned within the valve annulus. The system can alsoinclude a control wire operably attached to the implant for positioningthe implant within the heart valve annulus. In some embodiments, thesystem also includes at least one tissue anchor for attaching theimplant to tissue of the valve annulus. In some embodiments, the systemalso includes a self-expandable support structure operably connected tothe transvalvular implant, for securing the implant to tissue of thevalve annulus. Also disclosed herein is a transvalvular intraannularband that can include an elongate body having a first end, a firstanchoring portion located proximate the first end, a second end, asecond anchoring portion located proximate the second end, and a centralportion connected to the first end and the second end. In someembodiments, the central portion has a convex arcuate shape and caninclude a plurality of crossing struts encapsulated by a thermoplasticmaterial, the crossing struts intersecting at an intersection zone, thecentral portion displaced transversely from the intraannular plane whichincludes the mitral valve annulus and is transverse to the direction ofblood flow when the band is attached to the annulus. The central portioncan extend generally along a second plane which is perpendicular to theintraannular plane, the second plane including the first end and thesecond end; wherein the first end and the second end are configured tobe attached to the mitral valve annulus within the intraannular planeand the central portion is configured to be convex in the direction ofthe ventricle to support the mitral valve leaflets at a point displacedtoward the ventricle from the intraannular plane. The first end and thesecond end can reside on a generally septal-lateral axis transverse tothe coaptive edges of the mitral valve leaflets when the band isattached to the mitral valve annulus. In some embodiments, the banddoes, or does not, comprise an annuloplasty ring, stent-valve, orreplacement valve leaflets.

In some embodiments, disclosed herein is a system for delivering andanchoring an implant to a valve annulus. The system can include ananchor catheter configured to deliver a subannular anchor to a valveannulus of a heart of a patient. The anchor catheter can include aportion configured to create a hole in the valve annulus through whichthe anchor catheter delivers the subannular anchor. In some embodiments,the subannular anchor comprises a first configuration in which thesubannular anchor has a low profile to be delivered through the hole anda second configuration in which the subannular anchor is expanded. Insome embodiments, the subannular anchor comprises a suture. The systemcan include a transvalvular band configured to be delivered by slidingthe transvalvular band along the suture toward the valve annulus. Insome embodiments, the transvalvular band includes a first anchoringportion and wherein the suture is configured to extend through the firstanchoring portion.

In some embodiments, the system can include a locking clip configured tobe delivered by sliding the locking clip along the suture toward thevalve annulus. In some embodiments, the anchor catheter is configured todeliver a plurality of subannular anchors. In some embodiments, theanchor catheter is configured to deliver four subannular anchors. Insome embodiments, the anchor catheter is configured to deliver twosubannular anchors on each leaflet. In some embodiments, the subannularanchor has a star configuration in which a plurality of prongs foldoutward. In some embodiments, the subannular anchor compresses withtension, wherein the anchor catheter applies tension to compress thesubannular anchor in the first configuration. In some embodiments, thetransvalvular band comprises the first anchoring portion and a secondanchoring portion, and a central portion therebetween. In someembodiments, the central portion comprises a convex arcuate shape andcomprises a plurality of crossing struts encapsulated by a material. Insome embodiments, the transvalvular band comprises the first anchoringportion and a second anchoring portion, and a central portiontherebetween, wherein each anchoring portion is configured to acceptsutures connected to subannular anchors therethrough. In someembodiments, the system can include a trimming catheter, wherein thetrimming catheter is configured to slide along the suture after thetransvalvular band is delivered and trims the excess suture. In someembodiments, the system can include a catheter configured to allowtransseptal access. In some embodiments, at least one catheter issteerable. In some embodiments, the system can include a means forsuture management. In some embodiments, the anchor catheter furthercomprises a lumen for each suture. In some embodiments, the anchorcatheter comprises four lumens, each lumen configured to receive asuture connected to a subannular anchor. In some embodiments, the anchorcatheter comprises a sleeve for each suture. In some embodiments, thesystem can include four sleeves, each sleeve configured to receive asuture connected to a subannular anchor. In some embodiments, the anchorcatheter is configured to apply energy to create the hole.

Also disclosed herein is a method for delivering and anchoring animplant to a valve annulus of a valve. The method can includepercutaneously creating a hole in the valve annulus to deliver asubannular anchor. The method can include delivering a subannular anchorthrough the hole in the valve annulus in a low profile configuration andexpanding the subannular anchor on the ventricular side of the annulus.In some embodiments, the subannular anchor comprises a suture extendingto the upstream side of the annulus relative to a direction of bloodflow. The method can include delivering a transvalvular band to thevalve annulus by sliding the transvalvular band along the suture towardthe valve annulus.

In some embodiments, the method can include delivering a locking clip bysliding the locking clip along the suture toward the valve annulus. Insome embodiments, the locking clip slides freely along the suture in afirst direction, but resists movement in a second direction, oppositethe first direction. In some embodiments, the method can includedelivering a plurality of subannular anchors. In some embodiments, themethod can include delivering four subannular anchors. In someembodiments, the method can include delivering two subannular anchors onthe posterior annulus and two subannular anchors on the anteriorannulus. In some embodiments, the subannular anchor is reversible. Insome embodiments, the method can include applying tension to compressthe subannular anchor. In some embodiments, creating the hole in thevalve annulus comprises applying energy to the valve annulus. In someembodiments, creating the hole in the valve annulus comprisesmechanically puncturing the valve annulus. In some embodiments, thevalve is a mitral valve. In some embodiments, the method can includecreating a second hole in the valve annulus to deliver a secondsubannular anchor, and delivering the second subannular anchor throughthe second hole in the valve annulus, wherein the first hole and thesecond hole are spaced apart.

In some embodiments, disclosed herein is a method of using a subannularanchor to percutaneously anchor an implant in a valve annulus. Themethod can include providing a subannular anchor. In some embodiments,the subannular anchor comprises a first configuration in which thesubannular anchor has a low profile and a second configuration in whichthe subannular anchor is expanded. In some embodiments, the subannularanchor comprises a suture. The method can include threading the sutureof the subannular anchor through an anchoring portion of a transvalvularband.

In some embodiments, the method can include providing an anchor catheterconfigured to deliver the subannular anchor. In some embodiments, theanchor catheter is configured to apply energy to tissue. In someembodiments, the method can include providing a delivery catheterconfigured to deliver the transvalvular band to the valve annulus. Insome embodiments, the method can include threading the suture throughthe delivery catheter after threading the suture through the anchoringportion of the transvalvular band. In some embodiments, the method caninclude compressing the transvalvular band after threading the suturethrough the anchoring portion of the transvalvular band. In someembodiments, the method can include threading the suture of thesubannular anchor through a locking clip. In some embodiments, themethod can include threading the suture through the delivery catheterafter threading the suture the locking clip. In some embodiments, themethod can include threading the suture through a locking clip afterthreading the suture through the anchoring portion of the transvalvularband. In some embodiments, the method can include providing a trimmingcatheter configured to trim the suture.

In some embodiments, disclosed herein is a method for treating mitralvalve regurgitation. The method can include percutaneously delivering afirst subannular anchor coupled to a first suture, wherein the firstsuture extends through the annulus. The method can includepercutaneously delivering a second subannular anchor coupled to a secondsuture, wherein the second suture extends through the annulus. Themethod can include cinching the first suture and the second suture witha transvalvular implant.

In some embodiments, cinching comprises cinching the posterior annulustoward the anterior annulus. In some embodiments, cinching facilitatesproper leaflet coaptation. In some embodiments, the first suture extendsin a straight path through a pilot hole in the posterior annulus. Insome embodiments, the second suture extends in a straight path through apilot hole in the anterior annulus. In some embodiments, the method caninclude delivering a third subannular anchor coupled to a third suture,wherein the third suture extends through the annulus. In someembodiments, the method can include delivering a fourth subannularanchor coupled to a fourth suture, wherein the fourth suture extendsthrough the annulus. In some embodiments, the first suture and the thirdsuture are coupled to a first end of the transvalvular implant and thesecond suture and the fourth suture are coupled to a second end of thetransvalvular implant. In some embodiments, the first suture and thethird suture are coupled to the posterior annulus and the second sutureand the fourth suture are coupled to the anterior annulus. In someembodiments, the method can include ablating tissue to create a pilothole to deliver the first anchor subannularly. In some embodiments, themethod can include sequentially delivering the first subannular anchorand the second subannular anchor.

In some embodiments, disclosed herein is a system for delivering andanchoring an implant to a valve annulus. The system can include ananchor catheter configured to deliver a subannular anchor to a valveannulus of a heart of a patient. In some embodiments, the anchorcatheter can include a portion configured to create a hole in the valveannulus through which the anchor catheter delivers the subannularanchor. In some embodiments, the subannular anchor comprises a firstconfiguration in which the subannular anchor has a low profile to bedelivered through the hole and a second configuration in which thesubannular anchor is expanded. In some embodiments, the subannularanchor comprises a suture. The system can include a transvalvularimplant configured to be delivered by sliding the transvalvular implantalong the suture toward the valve annulus. In some embodiments, thetransvalvular implant includes a first anchoring portion. In someembodiments, the suture is configured to extend through the firstanchoring portion.

In some embodiments, the system can include a locking clip configured tobe delivered by sliding the locking clip along the suture toward thevalve annulus. In some embodiments, the anchor catheter is configured todeliver a plurality of subannular anchors. In some embodiments, theanchor catheter is configured to deliver four subannular anchors. Insome embodiments, the anchor catheter is configured to deliver twosubannular anchors on each leaflet. In some embodiments, the subannularanchor has a star configuration in which a plurality of prongs foldoutward. In some embodiments, the subannular anchor compresses withtension, wherein the anchor catheter applies tension to compress thesubannular anchor in the first configuration. In some embodiments, thetransvalvular implant comprises the first anchoring portion and a secondanchoring portion, and a central portion therebetween, wherein thecentral portion comprises a convex arcuate shape and comprises aplurality of crossing struts encapsulated by a material. In someembodiments, the transvalvular implant comprises the first anchoringportion and a second anchoring portion, and a central portiontherebetween, wherein each anchoring portion is configured to acceptsutures connected to subannular anchors therethrough. In someembodiments, the system can include a trimming catheter, wherein thetrimming catheter is configured to slide along the suture after thetransvalvular implant is delivered and trims the excess suture. In someembodiments, the system can include a catheter configured to allowtransseptal access. In some embodiments, at least one catheter issteerable. In some embodiments, the system can include a means forsuture management. In some embodiments, the system can include a lumenfor each suture. In some embodiments, the system can include fourlumens, each lumen configured to receive a suture connected to asubannular anchor. In some embodiments, the system can include a sleevefor each suture. In some embodiments, the system can include foursleeves, each sleeve configured to receive a suture connected to asubannular anchor. In some embodiments, the anchor catheter isconfigured to apply energy to create the hole.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a simplified cross-sectional view of the heart with a normalmitral valve during systole. The intraannular plane is illustratedrelative to supraannular and infrannular.

FIG. 2 is a cross-sectional view of the heart with a normal mitral valveduring diastole. The axis of the mitral valve is illustrated, and shownpiercing the intraannular plane.

FIG. 3 is a bottom view of the normal mitral valve of FIG. 1 duringsystole looking from the left atrium to the left ventricle.

FIG. 4 is a bottom view of the normal mitral valve of FIG. 2 duringdiastole looking from the left atrium to the left ventricle.

FIG. 5 is a cross-sectional schematic view of the normal mitral valve ofFIG. 1 during systole, illustrating the depth of the coaption zone.

FIG. 6 is a cross-sectional schematic view of the normal mitral valve ofFIG. 2 during diastole.

FIG. 7 is a cross-sectional view of the heart during systole showing amitral valve with a prolapsed anterior leaflet caused by the rupture ofthe chordae tendineae attached to the anterior leaflet.

FIG. 8 is a bottom view of the mitral valve of FIG. 7 having a prolapsedanterior leaflet looking from the left atrium to the left ventricle.

FIG. 9 is a cross-sectional view of the heart during systole showing amitral valve with a prolapsed posterior leaflet caused by the rupture ofthe chordae tendineae attached to the posterior leaflet.

FIG. 10 is a bottom view of the mitral valve of FIG. 9 having aprolapsed posterior leaflet looking from the left atrium to the leftventricle.

FIG. 11 is a cross-sectional view of the heart during systole showing amitral valve with anterior leaflet prolapse.

FIG. 11A is a cross sectional view as in FIG. 11, showing posteriorleaflet prolapse.

FIG. 11B is a cross sectional view as in FIG. 11, showing bileafletprolapse with mitral regurgitation.

FIG. 11C illustrates a dilated mitral annulus with little or no coaptionof both leaflets causing central mitral regurgitation in ischemiccardiomyopathy.

FIG. 12 is a top view of an embodiment of a transvalvular band.

FIG. 13 is a side view of the transvalvular band of FIG. 12.

FIG. 14 is a cross-sectional view of a transvalvular band with atriangular cross-section.

FIG. 15 is a cross-sectional view of a transvalvular band with an oblongcross-section.

FIG. 16 is a cross-sectional view of a transvalvular band with acircular cross-section.

FIG. 17 is a cross-sectional view of a transvalvular band with arectangular cross-section.

FIG. 18 is a top view of another embodiment of a transvalvular band.

FIGS. 19A and B show a perspective view of yet another embodiment of atransvalvular band, with a widened coaptive edge support portion.

FIGS. 20-23 are top views of other embodiments of a transvalvular band.

FIG. 23A shows a central mitral transvalvular band with posteriorannuloplasty ring.

FIG. 23B shows an intraannular band formed from a length of wire.

FIGS. 24-27 are side views of other embodiments of a transvalvular band.

FIG. 28 is a cross-sectional view of a heart during systole with atransvalvular band implanted in the mitral annulus.

FIG. 29 is a bottom view of the mitral valve of FIG. 28 during systolewith a transvalvular band implanted in the mitral annulus looking fromthe left atrium to the left ventricle.

FIG. 30 is a cross-sectional view of a heart during diastole with mitralvalve and a transvalvular band implanted in the mitral annulus.

FIG. 31 is a bottom view of the mitral valve of FIG. 30 during diastolewith a transvalvular band implanted in the mitral annulus looking fromthe left atrium to the left ventricle.

FIG. 32 is a cross-sectional schematic view of the mitral valve of FIG.28 during systole with a transvalvular band implanted in the mitralannulus.

FIG. 33 is a cross-sectional schematic view of the mitral valve of FIG.32 during systole without the transvalvular band implanted in the mitralannulus.

FIG. 34 is a cross-sectional schematic view of the mitral valve of FIG.30 during diastole with the transvalvular band implanted in the mitralannulus.

FIG. 35 is a cross-sectional schematic view of the mitral valve of FIG.34 during diastole without the transvalvular band implanted in themitral annulus.

FIG. 36 is a bottom view of the mitral valve during systole with anotherembodiment of the transvalvular band implanted in the mitral annuluslooking from the left atrium to the left ventricle.

FIG. 37 is a cross-sectional view of a transvalvular band with atransverse leaflet support.

FIG. 38 is a cross-sectional schematic view of the mitral valve treatedwith the transvalvular band of FIG. 37 and an Alfieri type procedure.

FIG. 39 is a schematic cross-sectional view of the heart, showing atypical antegrade approach to the mitral valve by way of a transseptalcrossing.

FIG. 40 is a cross sectional view as in FIG. 39, showing placement of aguidewire through the mitral valve.

FIG. 41 is a cross sectional view of the heart showing a typicalretrograde approach to the mitral valve by way of a femoral arteryaccess.

FIG. 42 shows a retrograde approach as in FIG. 41, with a guidewireplaced across the mitral valve.

FIG. 43A is a schematic view of the distal end of a percutaneousdeployment catheter having a self-expandable implant positioned therein.

FIG. 43B is a schematic view as in FIG. 43A, with the implant partiallydeployed from the catheter.

FIG. 43C is a schematic view of the deployment catheter showing theimplant fully expanded at the deployment site, but still tethered to thedeployment catheter.

FIG. 43D is a side elevational view of the implant of FIG. 43C.

FIG. 43E is an end view taken along the line 43E-43E of FIG. 43D.

FIG. 44A is a side elevational perspective view of an anchor deploymentcatheter in accordance with the present invention.

FIG. 44B is a cross sectional view taken along the line 44B-44B of FIG.44A.

FIG. 44C is a cross sectional side view of the anchor deploymentcatheter of FIG. 44A.

FIG. 45A is a schematic plan view of a self-expandable transvalvularband in accordance with the present invention.

FIG. 45B is a side elevational view of the transvalvular band of FIG.45A shown in a reduced crossing profile (folded) configuration, andattached to three control wires.

FIG. 46A is a cut-away perspective view of the distal end of adeployment catheter having a self-expandable implant contained therein.

FIG. 46B is a deployment catheter as in FIG. 46A, with the implantpartially deployed.

FIG. 46C is a view as in FIG. 46B, showing the implant released from thedeployment catheter, but connected to three control wires.

FIG. 46D is a view as in FIG. 46C with a tissue anchor deploymentcatheter.

FIG. 46E is a cross sectional view of a mitral valve, having an implantanchored in place and the deployment catheter removed.

FIG. 47A is a side elevational view of the distal end of a deploymentcatheter, having an implant partially deployed therefrom.

FIG. 47B is a schematic view of the catheter and implant of FIG. 47A,during implantation at the mitral valve.

FIG. 47C is a schematic view as in FIG. 47B, with the tissue anchordeployment guides removed.

FIG. 47D is a schematic view as in FIG. 47C, with the implant configuredto move coaption earlier in the cardiac cycle.

FIG. 47E is a schematic view of the implant of FIG. 47D, with thedeployment catheter removed.

FIG. 48A is schematic cross sectional view of a transapical deploymentdevice positioned across the mitral valve.

FIG. 48B is a schematic view of the device of FIG. 48A, with tissueanchors engaged at the mitral valve annulus.

FIG. 48C is a schematic view as in FIG. 48B, with the deploymentcatheter withdrawn through the mitral valve.

FIG. 48D is a schematic view as in FIG. 48C, in an embodiment having atransventricular support.

FIGS. 49A through 49G illustrate an implantation sequence for atransvalvular band at the mitral valve, via a transapical access.

FIG. 49H shows an alternate end point, in which the transvalvular bandis additionally provided with a transventricular truss and an epicardialanchor.

FIG. 50A is a side elevational schematic view of the distal end of adeployment catheter, having a rolled up transvalvular band therein.

FIG. 50B is an illustration as in FIG. 50A, following distal deploymentof the transvalvular band.

FIGS. 51A and 51B illustrate top plan views and side views of atransvalvular band in accordance with the present invention.

FIG. 51C illustrates a perspective view of one embodiment of atransvalvular band in a rolled-up configuration and mounted on adelivery mandrel.

FIG. 51D illustrates a view of at least a non-linear portion of a strutof FIG. 51B.

FIGS. 52A through 52C illustrate a transvalvular band, with a “t-tag”deployment system and suture tensioning feature.

FIG. 52D illustrates an embodiment of a plurality of tissue anchorslooped together on a suture.

FIG. 53 is a side elevational perspective view of a transvalvular bandin accordance with the present invention.

FIG. 54 is a schematic illustration of various suture lockconfigurations for use on transvalvular bands of the present invention.

FIG. 55 is a side elevational perspective view of a transvalvular band,having barbed tissue anchors thereon.

FIG. 56 is a side elevational perspective view of a transvalvular bandin accordance with the present invention, having arcuate tissue anchorsthereon.

FIGS. 56A-B are graphs illustrating data regarding chordal physiologicforce experiments. FIGS. 57A-D illustrate another embodiment of atransvalvular band. FIGS. 57E-H illustrate views of the underlyingskeleton layer of the transvalvular band, according to some embodiments.

FIG. 58 is a simplified cross-sectional view of the heart.

FIGS. 59A-59C are views of a catheter system, according to someembodiments.

FIG. 60 illustrates examples of access locations.

FIGS. 61A-61G illustrates various features of the catheter system,according to some embodiments.

FIG. 62 is a side perspective view of an embodiment of a needlecatheter.

FIG. 63A is a side perspective view of an embodiment of a needle and anenergy tip. FIG. 63B is a front perspective view of the needle and theenergy tip of FIG. 63A. FIG. 63C are various views of an alternativeembodiment of a needle and an energy tip.

FIGS. 64A-64E are various perspective views of the delivery of aretainer, according to some embodiments.

FIGS. 65A-65H are various perspective views of the delivery of atransvalvular bridge, according to some embodiments.

FIG. 66A is a front perspective view of a clip. FIG. 66B is a frontperspective view of the clip of FIG. 66A and a suture, according to someembodiments.

FIG. 67A is a side perspective view of a handle, according to someembodiments. FIG. 67B is a cross-sectional perspective view of thehandle of FIG. 67A.

FIGS. 68A-68B are side perspective views of a steerable catheter,according to some embodiments. FIGS. 68C-68D are side perspective viewsof a steerable needle catheter. FIG. 68E is a perspective view of aneedle catheter.

FIG. 69A-69B are perspective views of a handle, according to someembodiments.

FIG. 70 is a simplified view of various access locations, according tosome embodiments.

FIGS. 71-73 are simplified views of the heart and the location of thetransvalvular band, according to some embodiments.

FIGS. 74-76 are views of the transvalvular band, according to someembodiments.

FIGS. 77-83 are views of an open procedure method, according to someembodiments.

FIGS. 84-86 are views of a minimally invasive surgery method, accordingto some embodiments.

FIGS. 87-91 are views of a transcatheter system, according to someembodiments.

FIGS. 92-93 are views of subannular anchoring, according to someembodiments.

FIGS. 94-96 are views of transcatheter surgery, according to someembodiments.

FIGS. 97A-97E are views of a transcatheter system, according to someembodiments.

FIG. 98 is a view of the percutaneous insertion of the transcathetersystem of FIGS. 97A-97E.

FIGS. 99A-100B are views of subannular anchoring and anchor placement,according to some embodiments.

FIG. 101 is a view of preliminary cinching, according to someembodiments.

FIGS. 102A-102D are views of suture threading and insertion of thetransvalvular bridge, according to some embodiments.

FIGS. 103A-103D are views of an embodiment of a transvalvular bridge.

FIG. 104 is a schematic view of the threading of sutures, according tosome embodiments.

FIG. 105 is a schematic view of the trimming of sutures, according tosome embodiments.

FIGS. 106A-106E are views of a transcatheter system, according to someembodiments.

FIGS. 107A-107C are views of transseptal access, according to someembodiments.

FIGS. 108A-108C are views of introduction of the transcatheter system,according to some embodiments.

FIGS. 109A-110B are views of anchor deployment, according to someembodiments.

FIGS. 111A-111C are views of cinching, according to some embodiments.

FIGS. 112A-112B are schematic views of transducer positions and planesof the heart, according to some embodiments.

FIGS. 113A-113T are schematic views of methods of use of a transcathetersystem, according to some embodiments.

DETAILED DESCRIPTION

FIG. 1 illustrates a cross-sectional view of the heart 10 with a normalmitral valve 18 in systole. As illustrated, the heart 10 comprises theleft atrium 12 which receives oxygenated blood from the pulmonary veins14 and the left ventricle 16 which receives blood from the left atrium12. The mitral valve 18 is located between the left atrium 12 and leftventricle 16 and functions to regulate the flow of blood from the leftatrium 12 to the left ventricle 16. During ventricular diastole, themitral valve 18 is open which allows blood to fill the left ventricle16. During ventricular systole, the left ventricle 16 contracts, whichresults in an increase in pressure inside the left ventricle 16. Themitral valve 18 closes when the pressure inside the left ventricle 16increases above the pressure within the left atrium 12. The pressurewithin the left ventricle 16 continues increasing until the pressurewithin the left ventricle 16 exceeds the pressure within the aorta 20,which causes the aortic valve 22 to open and blood to be ejected fromthe left ventricle and into the aorta 20.

The mitral valve 18 comprises an anterior leaflet 24 and a posteriorleaflet 26 that have base portions that are attached to a fibrous ringcalled the mitral valve annulus 28. Each of the leaflets 24 and 26 hasrespective free edges 36 and 38. Attached to the ventricular side of theleaflets 24 and 26 are relatively inelastic chordae tendineae 30. Thechordae tendineae 30 are anchored to papillary muscles 32 that extendfrom the intraventricular septum 34. The chordae tendineae 30 andpapillary muscle 32 function to prevent the leaflets 24 and 26 fromprolapsing and enable proper coaptation of the leaflets 24 and 26 duringmitral valve 18 closure. Also shown schematically is line 9 through thevalve annulus 28 representing the intraannular plane. Arrow 8 pointssupraannularly, toward the left atrium 12, while arrow 7 pointsinfraannularly, toward the left ventricle 16.

FIG. 2 illustrates a cross-sectional view of the heart 10 with a normalmitral valve 18 in diastole. After the left ventricle 16 has ejected theblood into the aorta, the left ventricle relaxes, which results in adrop in pressure within the left ventricle 16. When the pressure in theleft ventricle 16 drops below the pressure in the aorta 20, the aorticvalve 22 closes. The pressure within the left ventricle 16 continuesdropping until the pressure in the left ventricle 16 is less than thepressure in the left atrium 12, at which point the mitral valve 18opens, as shown in FIG. 2. During the early filling phase, bloodpassively fills the left ventricle 16 and this accounts for most of thefilling of the left ventricle 16 in an individual at rest. At the end ofthe filling phase, the left atrium 12 contracts and provides a finalkick that ejects additional blood into the left ventricle. Also shown isintraannular plane 9 as described above, and line 6 representing thelongitudinal axis 6 of the valve 18.

FIG. 3 illustrates a bottom view of normal mitral valve 18 in systole,looking from the left atrium and to the left ventricle. As shown, theanterior leaflet 24 and posterior leaflet 26 are properly coapted,thereby forming a coaptive edge 40 that forms a seal that preventsretrograde flow of blood through the mitral valve 18, which is known asmitral regurgitation. FIG. 4 illustrates a bottom view of normal mitralvalve 18 in diastole. FIG. 5 provides a side cross-sectional view of anormal mitral valve 18 in systole. As shown in FIG. 5, the valveleaflets 24 and 26 do not normally cross the plane P defined by theannulus and the free edges 36 and 38 coapt together to form a coaptiveedge 40.

FIG. 5 also illustrates a coaption zone 41. Preferably the depth ofcoaption (length of zone 41 in the direction of blood flow, in which theleaflets 24 and 26 are in contact) is at least about 2 mm or 5 mm, andis preferably within the range of from about 7 mm to about 10 mm for themitral valve.

Thus, implantation of the devices in accordance with the presentinvention preferably achieves an increase in the depth of coaption. Atincrease of at least about 1 mm, preferably at least about 2 mm, and insome instances an increase of at least about 3 mm to 5 mm or more may beaccomplished.

In addition to improving coaption depth, implantation of devices inaccordance with the present invention preferably also increase the widthof coaptation along the coaption plane. This may be accomplished, forexample, by utilizing an implant having a widened portion for contactingthe leaflets in the area of coaption such as is illustrated inconnection with FIGS. 19A and 19B below. A further modification of thecoaptive action of the leaflets which is accomplished in accordance withthe present invention is to achieve early coaption. This is accomplishedby the curvature or other elevation of the implant in the ventricledirection. This allows the present invention to achieve early coaptionrelative to the cardiac cycle, relative to the coaption point prior toimplantation of devices in accordance with the present invention.

FIGS. 4 and 6 illustrate normal mitral valve 18 in diastole. As shown,the anterior leaflet 24 and posterior leaflet 26 are in a fully openedconfiguration which allows blood to flow from the left atrium to theleft ventricle.

FIGS. 7 and 8 illustrate a heart 10 in systole where the anteriorleaflet 24 of the mitral valve 18 is in prolapse. Anterior leaflet 24prolapse can be caused by a variety of mechanisms. For example, asillustrated in FIG. 7, rupture 42 of a portion of the chordae tendineae30 attached to the anterior leaflet 24 can cause the free edge 36 of theanterior leaflet 24 to invert during mitral valve 18 closure. As shownin FIG. 8, inversion 44 of the anterior leaflet 24 can prevent themitral valve leaflets 24 and 26 from properly coapting and forming aseal. This situation where the free edge 36 of the anterior leaflet 24crosses into the left atrium 12 during mitral valve 18 closure can leadto mitral regurgitation.

Similarly, FIGS. 9 and 10 illustrate posterior leaflet 26 prolapsecaused by a rupture of the chordae tendineae 30 attached to theposterior leaflet 26. In this case, the posterior leaflet 26 can invertand cross into the left atrium 12 during mitral valve 18 closure. Theinversion of the posterior leaflet 26 prevents the mitral valve leaflets24 and 26 from properly coapting and forming a seal, which can lead tomitral regurgitation.

Mitral regurgitation can also be caused by an elongated valve leaflet 24and 26. For example, an elongated anterior leaflet 24, as shown in FIG.11, can prevent the valve leaflets 24 and 26 from properly coaptingduring mitral valve 18 closure. This can lead to excessive bulging ofthe anterior leaflet 24 into the left atrium 12 and misalignment of thefree edges 36 and 38 during coaptation, which can lead to mitralregurgitation.

One embodiment of a transvalvular band 50 that would improve mitralvalve leaflet 24 and 26 coaptation and prevent or reduce mitralregurgitation is illustrated in FIGS. 12 and 13. FIG. 12 provides a topview of the transvalvular band 50 while FIG. 13 provides a side view ofthe transvalvular band 50. In this embodiment, the transvalvular band 50comprises an elongate and curved structure with a first end 52, a secondend 54, a central portion 64 located between the two ends 52 and 54, anda length that is capable of extending across the annulus. The leafletcontact surface 56 is convex along the longitudinal axis, as bestillustrated in FIG. 13. In other embodiments, the leaflet contactsurface 56 can have a different shape and profile. For example, thecontact surface 56 can be concave, straight, a combination of convex,concave and/or straight, or two concave or straight portions joinedtogether at an apex. As illustrated in FIG. 12, the transvalvular band50 can have a substantially constant width between the first end 52 andthe second end 54. The first end 52 has a first anchoring portion 58 andthe second end 54 has a second anchoring portion 60.

The anchoring portions 58 and 60 can have holes 62 for sutures thatallow the transvalvular band 50 to be secured to the annulus.Alternatively, in other embodiments the anchoring portions 58 and 60 canhave other means for securing the transvalvular band 50 to the annulus.For example, the anchoring portions 58 and 60 can be made of a membraneor other fabric-like material such as Dacron or ePTFE. Sutures can bethreaded directly through the fabric without the need for distinct holes62. The fabric can be attached to the other portions of thetransvalvular band 50 by a variety of techniques. For example, thefabric can be attached to the other portions of the transvalvular band50 with the use of an adhesive, by suturing, by tying, by clamping or byfusing the parts together. Another non-limiting technique of securingthe transvalvular band to the annulus is to coat a malleable metal basismaterial, which creates structure for securing a skeleton of thetransvalvular band, with a polymer such as silicone and bonding amaterial, such as PET (i.e., Dacron) velour for comprehensive tissueingrowth when desired.

The central portion of the transvalvular band 50 can have a variety ofcross-sectional shapes, as illustrated in FIGS. 14-17. For example, thecross sectional shape can be substantially rectangular, circular, oblongor triangular. The edges of the transvalvular band 50 can be rounded orotherwise configured so that the transvalvular band 50 presents anatraumatic surface 51 to the valve leaflets. In some embodiments, thecross-section can be oriented in a particular fashion to enhanceperformance of the transvalvular band 50. For example as shown in FIG.14, a transvalvular band 50 with a triangular cross section can bedesigned so that a relatively larger surface 56 of the triangle contactsthe valve leaflets while a lower profile leading edge 53 of the triangleopposite the surface 51 faces the left atrium. This configuration allowsa larger surface area to make contact with and support the mitral valveleaflets, while also presenting a more streamlined shape that providesless resistance to blood flowing from the left atrium to the leftventricle. Decreasing the resistance to blood flow is desirable becauseit can reduce turbulence and reduce the impedance of the transvalvularband 50 on the filling of the left ventricle. Similarly, thetransvalvular bands 50 with an oblong or rectangular cross-section canbe oriented to either increase the surface area for contact with thevalve leaflets, or be oriented to reduce the resistance to blood flow.

The dimensions of the transvalvular band 50 will vary, depending uponthe specific configuration of the band 50 as well as the intendedpatient. In general, transvalvular band 50 will have an axial lengthfrom first end 52 to second end 54 within the range of from about 20 mmto about 32 mm. In one embodiment, intended for a typical male adult,the axial length of the transvalvular band 50 is about 24 mm to 26 mm.The width of the transvalvular band 50 in the central zone 64 may bevaried depending upon the desired performance, as will be discussedherein. In general, the trailing surface 51 against which leaflets willseat is preferably large enough to minimize the risk of erosionresulting from repeated contact between the closed leaflets and theimplant. The width of the leading edge 53 is preferably minimized, asdiscussed above, to minimize flow turbulence and flow obstruction. Ingeneral, widths of the surface 51 measured perpendicular to the flow ofblood are presently contemplated to be less than about 5 mm, and oftenwithin the range of from about 5 mm to about 10 mm in the zone ofcoaptation.

In some embodiments as illustrated in FIG. 18, the central portion 64 ofthe transvalvular band 50 can be narrower in width, measuredperpendicular to blood flow than the first and second anchoring portions58 and 60. By narrowing the central portion 64, the resistance to bloodflow can be reduced. However, narrowing the central portion 64 reducesthe surface area of the leaflet contact surface 56 that supports thevalve leaflets.

In the embodiment illustrated in FIG. 18, the narrowed central portion64 is separated from the first anchoring portion 58 and second anchoringportion 60 by a first shoulder 57 and second shoulder 59. The length ofthe central portion 64, between first shoulder 57 and second shoulder 59can be less than about 50% of the overall length of the device, or lessthan about 30% of the overall length of the device if it is desired tominimize the obstruction in the center of the flow path, whilepresenting a wider transverse surface for supporting the leaflets whenthe valve is closed. Alternatively, the length of the central zone 64may be greater than 50%, and in some embodiments greater than 75% of theoverall length of the implant.

In some embodiments as illustrated in FIGS. 19A, 19B, 21 and 23, acoaptive edge support portion 66 of the central portion 64 of thetransvalvular band 50 can be wider than the adjacent portions of thetransvalvular band 50, leading up to and potentially including the firstand second anchoring portions 58 and 60. By increasing the width andsurface area of the coaptive edge support portion 66, more support canbe provided to the valve leaflets at the coaptive edge. This increasedsupport can increase the width of leaflet coaption. The other portionsof the central portion 64 can remain narrow to reduce the resistance toblood flow. The support portion 66 can be located at a fixed position oradjustable along the transvalvular band so that its position can beoptimized by the surgeon and then secured at a fixed point such as bysuturing, or removed if deemed unnecessary.

In one implementation of the invention, the transvalvular band comprisesa first component for primary reduction and a second component for fineadjustment. For example, the device illustrated in FIG. 19A may beprovided with an adjustable (e.g. slidable) support portion 66. Thetransvalvular band may be positioned across the annulus as has beendescribed herein, and hemodynamic function of the valve may beevaluated. The support portion 66 may thereafter be adjusted along thelength of the transvalvular band to treat residual leakage or otherwiseoptimize the functionality of the implant such as by increasing the zoneof coaptation. The second component (e.g. support portion 66) maythereafter be fixed with respect to the transvalvular band such as bysutures, clips, adhesives, or other techniques known in the art.Alternatively, the second portion may be separate from and connectableto the transvalvular band such as stitching, clips, suturing or othertechnique known in the art.

In addition, the coaptive edge support portion 66 can be offset from thecenter of the transvalvular band 50, to reflect the asymmetry betweenthe anterior leaflet and the posterior leaflet. For example, thecoaptive edge support portion 66 can be positioned closer to the firstanchoring portion 58 than to the second anchoring portion 60. In certainembodiments, the edge support portion 66 will be centered about a pointwhich is within the range of from about 20% to about 45% of the overalllength of the implant from the closest end.

FIG. 20 illustrates another embodiment of a transvalvular band 50 thatis a modification of the transvalvular band 50 shown in FIG. 18. Asillustrated in FIG. 20, the transvalvular band 50 has a narrow centralportion 64 that provides relatively low resistance to blood flow.However, the first and second anchoring portions 58 and 60 extendfurther in a lateral direction, and can be arcuate to conform to themitral valve annulus. These laterally extended anchoring portions 58 and60 provide additional anchoring of the transvalvular band 50 and canhelp improve the stability of the device after implantation. Thelaterally extending anchoring portion 58 and 60 may be provided with anyof a variety of structures for facilitating anchoring to the valveannulus. For example, they may be provided with a plurality of apertures61, for conventional stitching or to receive any of a variety of clipsor tissue anchors. The anchoring portions may alternatively be providedwith any of a variety of barbs or hooks, or may be provided with afabric covering such as a Dacron sleeve to facilitate sewing. Further,in some embodiments, this sewing ring may have an elastomeric core uponwhich the Dacron is secured to provide a more compliant structure tohold the implant. Measured in the circumferential direction (transverseto the longitudinal axis of the implant 50) the laterally extendinganchoring portions will have an arc length of greater than about 5 mm,and, in some embodiments, greater than about 1 cm. Arc lengths of atleast about 2 cm, and, in some embodiments, at least about 3 cm may beutilized, depending upon the desired clinical performance.

FIG. 21 illustrates another embodiment of a transvalvular band 50 withthe extended anchoring portions 58 and 60 and a wider, offset coaptiveedge support portion 66. This embodiment has the benefit of additionalstability provided by the extended anchoring portions 58 and 60 andenhanced support of the coaptive edge.

FIGS. 22 and 23 illustrate another embodiment of a transvalvular band 50which is combined with an annular ring 68. The annular ring 68 can beused as both a support for the transvalvular band 50 and, if desired,also to help stabilize the size and shape of the mitral valve annulusitself. In some embodiments, the annular ring 68 can be used to reducethe size of the mitral valve annulus and to bring the mitral valveleaflets closer together. This can be accomplished by, for example,suturing the mitral valve annulus to an annular ring 68 of smallerdiameter. In addition, the annular ring 68 provides additional supportand stability to the transvalvular band 50. The anchoring portions 58and 60 of the transvalvular band 50 can be formed integrally with theannular ring 68, or the anchoring portions 58 and 60 can be attached tothe annular ring by a variety of means, such as suturing, bonding,adhesives, stapling and fusing. FIG. 22 discloses an embodiment with anarrow central portion 64 while FIG. 23 discloses an embodiment with awider, offset coaptive edge support portion 66.

FIG. 23A illustrates a further implementation of the invention, adaptedto treat ischemic mitral regurgitation with posterior annuloplasty. Atransvalvular band 61 is provided for spanning the leaflet coaptionplane as has been described herein. Any of the features described inconnection with other transvalvular bands disclosed herein may beincorporated into the transvalvular band 61.

An arcuate posterior annuloplasty support 63 is connected to thetransvalvular band 61, and adapted to extend for an arc length along thenative annulus. In the illustrated embodiment, the support 63 extendsthrough an arc of approximately 180°, extending from a first trigoneattachment zone 65 to a second trigone attachment zone 67. Theattachment zones may be provided with sewing apertures, a fabriccovering, or other structure for facilitating attachment to tissue. Ingeneral, the transvalvular band 61 will have dimensions similar to thosedescribed elsewhere herein. The transverse dimension from first trigonezone 65 to second trigone zone 67 may be varied depending upon the sizeof the native annulus, but will generally be within the range of fromabout 35 mm to about 45 mm.

Referring to FIG. 23B, there is illustrated a transvalvular band inaccordance with the present invention, formed from a single length orseveral lengths of flexible wire. The bend angles and orientation of thestruts in the illustrated embodiment may be readily altered, toaccommodate the desired axes of compression which may be desirable for aparticular deployment procedure.

In general, the transvalvular band 71 comprises an elongate flexiblewire 73 formed into a serpentine pattern, for providing a support forthe valve leaflets as has been discussed herein. Although notillustrated in FIG. 23B, the wire 73 may be formed such that it bows orinclines in the direction of the ventricle to achieve early closure asis discussed elsewhere herein. The wire 73 may extend into a firstconnection section 75 and a second connection section 77. Each of theconnection sections 75 and 77 may be provided with a plurality ofeyelets 79, to receive sutures for attaching the implant to the valveannulus. The implant may be formed from any of a variety of flexiblematerials, including various polymers described elsewhere herein as wellas titanium, titanium alloy, Nitinol, stainless steel, elgiloy, MP35N,or other metals known in the art. This design has an advantage ofproviding a relatively large support footprint against the valveleaflets, while at the same time optimizing the area of open space topermit maximum blood flow therethrough. The design may be treated orcoated with silicone or other suitable material to eliminate untowardeffects such as thrombosis or corrosion. Treatments may be sequentialand include more than one listed but not limited to electropolishing,harperization, tumbling, pickling, plating, encapsulation or physicalvapor deposition of appropriate materials.

FIGS. 24-27 illustrate side views of transvalvular bands 50 withdifferent inclinations. One of the objectives of the present inventionis to not merely provide support to the leaflets during systole, but toelevate the plane of coaption in the direction of the ventricle, tocause early coaption (closure) relative to the cardiac cycle, as isdiscussed elsewhere herein. The variation in conditions, and otherpatient to patient variations may warrant production of thetransvalvular band of the present invention in an array of sizes and/orconfigurations, so that clinical judgment may be exercised to select theappropriate implant for a given case. Alternatively, the transvalvularband may be provided in an adjustable form or a modular form so that animplant of the desired configuration can be constructed or modifiedintraoperatively at the clinical site. In a three segment embodiment,such as that illustrated in FIGS. 24 through 27, a central segment maybe provided for positioning within the center of the flow path, orcentered on the coaptive edges of the leaflets. First and second endportions may be connected to the central portion, for supporting thecentral portion relative to the tissue anchors. First and second endportions may be provided in a variety of lengths and curvatures,enabling construction of a relatively customized modular implant as maybe desired for a particular patient.

For example, FIG. 24 illustrates a transvalvular band 50 with a centralportion 64 and two gently angled arm portions 70 and 72. The first andsecond ends 52 and 54 are displaced from the central portion 64 by aheight, h1 and h2, respectively. In FIG. 24, h1 and h2 are about equaland can range from about 0 mm to about 10 mm. Preferably h1 and h2 willbe at least about 2 mm and will often be at least about 4 mm or 6 mm ormore, but generally no more than about 10 mm or 12 mm.

FIG. 25 illustrates a transvalvular band 50 with a central portion 64and two sharply angled arm portions 70 and 72. The first and second ends52 and 54 are displaced from the central portion 64 by a height, h1 andh2, respectively. In FIG. 25, h1 and h2 are about equal and can rangefrom about 8 mm to about 12 mm. FIG. 26 illustrates a transvalvular band50 with a central portion 64, a highly angled first arm 70 and a gentlyangled second arm 72. The first and second ends 52 and 54 are displacedfrom the central portion 64 by a height, h1 and h2, respectively. InFIG. 26, h1 is greater than h2. The h1 ranges from about 6 mm to about10 mm, while h2 ranges from about 2 mm to about 6 mm. FIG. 27illustrates a transvalvular band 50 with a central portion 64, a gentlyangled first arm 70 and a highly angled second arm 72. The first andsecond ends 52 and 54 are displaced from the central portion 64 by aheight, h1 and h2, respectively. FIG. 27, may be a mirror image of FIG.26.

The transvalvular band 50 can be made of any of a variety of materialsthat are compatible with implantation within a patient's body and whichhas the requisite structural integrity to support the mitral valveleaflets. For example, suitable materials include titanium, titaniumalloys, stainless steel, stainless steel alloys, nitinol, elgiloy,MP35N, other metals and alloys, ceramics, and polymers such as PTFE,polycarbonate, polypropylene, UHMWPE, HDPE, PEEK, PEBAX and the like.

In order to reduce the thrombogenicity of the transvalvular band 50, thetransvalvular band 50 can be provided with a smooth surface orappropriately micro-texture the surface in some embodiments, such as viaa porous or microporous structure. Other factors such as surfacechemistry, energy, morphology, macrofeatures, and general materialproperties matching the in situ needs can also be considered intailoring the surface of the band. In addition, the transvalvular band50 can be coated with a variety of substances to reduce thrombogenicity.For example, the transvalvular band 50 can be coated with aantithrombogenic agent such as heparin, a polymer such as PTFE, or apolymer conjugated with heparin or another antithrombogenic agent.Heparin coatings can be achieved in a variety of methods, one of whichmay be to coat or drip the prosthesis in TDMAC-heparin(Tridodecylmethylammonium heparinate).

As illustrated in FIGS. 28-31, the transvalvular band 50 is implanted inthe plane of the mitral valve annulus 28 in a patient suffering fromanterior leaflet 26 prolapse caused by the rupture 42 of the chordaetendineae 30 attached to the anterior leaflet 26. Although a prolapsedanterior leaflet 26 is illustrated, it should be understood that themethod described herein is also applicable for treating other types ofprolapse, such as posterior leaflet prolapse and prolapse caused byelongated leaflets 24 and 26. The transvalvular band 50 can be attachedto the annulus 28 by a variety of techniques, such as sutures, anchors,barbs, stapes, self-expanding stents, or other techniques that are knownor are apparent to those of skill in the art.

As best illustrated in FIGS. 29 and 31, the transvalvular band 50 isoriented in the annulus 28 so that the transvalvular band 50 ispositioned approximately transversely to the coaptive edge 42 formed bythe closure of the mitral valve leaflets 24 and 26. The transvalvularband 50 can also be positioned over the prolapsed portion of theanterior leaflet 26 so that the transvalvular band 50 can directlysupport the prolapsed portion of the anterior leaflet 24 and keep theanterior leaflet 24 inferior to the plane of the mitral valve annulus28, i.e., elevated in the direction of the ventricle or of antegradeflow, thereby preventing or reducing prolapse and mitral regurgitation.

FIGS. 28 and 29 illustrate the effect of the transvalvular band 50 onthe mitral valve 18 during systole. As shown, both the anterior leaflet24 and the posterior leaflet 26 are supported by the transvalvular bandduring closure of the mitral valve 18. The arcuate transvalvular band 50functions to keep both leaflets 24 and 26 inferior to the plane of theannulus 28 and enables the leaflets 24 and 26 to form a coaptive edge40. Although a single transvalvular band 50 has been illustrated, insome embodiments, multiple transvalvular bands 50 such as two or threeor more can be implanted across the annulus 28 to provide additionalsupport to the mitral valve leaflets 24 and 26.

FIGS. 30 and 31 illustrate the effect of the transvalvular band 50 onthe mitral valve 18 during diastole. During diastole, the mitral valve18 opens so that blood can fill the left ventricle 16 from the leftatrium 12. As best illustrated in FIG. 31, the transvalvular band 50obstructs only a small portion of the mitral valve 18 opening, andtherefore, does not cause excessive resistance to blood flow.

FIGS. 32-35 are cross-sectional side views of the mitral valve 18 withand without the support of the transvalvular band 50. During systole,the mitral valve 18 closes. Without the transvalvular band 50, theanterior leaflet 24 crosses the plane P defined by the mitral valveannulus 28 and prolapse, which leads to mitral regurgitation, as shownin FIG. 33. However, by implanting the transvalvular band 50 in theannulus 28 such that the arcuate transvalvular band 50 arches towardsthe left ventricle and the central portion 64 is displaced from theplane P, the anterior leaflet 24 is prevented from prolapsing above theplane P thus eliminating or reducing retrograde flow (shown in FIG. 33).The leaflets 24 and 26 rest upon the transvalvular band 50 and thepressure exerted by the blood upon the distal portion of the leaflets 24and 26 form the coaptive edge 40. As illustrated in FIGS. 34 and 35, theperformance of the mitral valve 18 during diastole is not substantiallyaffected by the transvalvular band 50.

Although the method of implanting and positioning the transvalvular band50 has been illustrated with one embodiment of the transvalvular band50, other embodiments as described above can also be used. For example,FIG. 36 illustrates a transvalvular band 50 with a wider, offsetcoaptive edge support portion 66 that has been implanted in the mitralvalve annulus. As shown, the coaptive edge support 66 is offset so thatit positioned to support the coaptive edge of the mitral valve 18. Inaddition, the transvalvular band 50 can be used in conjunction withother devices and procedures, such as a separate or integrally attachedannular or annuloplasty ring described above. In addition, thetransvalvular band 50 can be used in conjunction with the Alfieriprocedure, where the tips of the mitral valve leaflets 24 and 26 aresutured 74 together, as shown in FIG. 38.

Referring to FIG. 37, there is illustrated a perspective view of atransvalvular band 50 having a transverse projection or support 51extending in the direction of the ventricle or in the direction ofdiastolic blood flow, which could be considered antegrade. The support51 has a width W, which may be at least about 3 mm, and in someembodiments, at least about 5 mm, and in other embodiments at leastabout 1.0 cm. The projection 51 may be utilized without an Alfieristitch, so that the leaflets of the mitral valve close against opposingside walls 53 and 55 of the projection 51. The projection 51 thus helpscenter the closure of the leaflets, as well as controlling the width ofcoaption. In addition, the band 50 is illustrated as convex in thedirection of the ventricle, to accomplish early closure as has beendiscussed herein.

The transvalvular band in accordance with the present invention can beimplanted via an open surgical procedure, via thoracotomy (e.g.transapically) or alternatively, via a percutaneous procedure using atranslumenally implantable embodiment. In the translumenally implantableembodiment, one or more transvalvular bands can be attached to aself-expandable support structure, such as a self-expandable ring orself-expandable stent having a relatively short axial length relative toits expanded diameter. The transvalvular band and the compressedself-expandable support structure are loaded into a catheter with aretractable outer sheath which is inserted percutaneously and advancedtranslumenally into or across the mitral valve. The retractable outersheath can be retracted to allow the self-expandable support structureto expand adjacent or against the annulus, thereby positioning the oneor more transvalvular bands in about the plane of the mitral annulus.Each transvalvular band can be characterized by a longitudinal axis, andthe transvalvular band is oriented in the mitral valve such that thelongitudinal axis of the transvalvular band in oriented substantiallytransversely to the coaptive edge of the mitral valve.

By “percutaneous” it is meant that a location of the vasculature remotefrom the heart is accessed through the skin, such as using needle accessthrough, for example, the Seldinger technique. However, it may alsoinclude using a surgical cut down procedure or a minimally invasiveprocedure. The ability to percutaneously access the remote vasculatureis well-known and described in the patent and medical literature.

Depending on the point of vascular access, the approach to the mitralvalve may be antegrade and require entry into the left atrium via thepulmonary vein or by crossing the interatrial septum. Alternatively,approach to the mitral valve can be retrograde where the left ventricleis entered through the aortic valve. Once percutaneous access isachieved, the interventional tools and supporting catheter(s) will beadvanced to the heart intravascularly where they may be positionedadjacent the target cardiac valve in a variety of manners, as describedelsewhere herein. While the methods will preferably be percutaneous andintravascular, many of the implants and catheters described herein will,of course, also be useful for performing open surgical techniques wherethe heart is beating or stopped and the heart valve accessed through themyocardial tissue. Many of the devices will also find use in minimallyinvasive procedures where access is achieved thorascopically and wherethe heart will usually be stopped but in some instances could remainbeating.

A typical antegrade approach to the mitral valve is depicted in FIG. 39.The mitral valve MV may be accessed by a standard approach from theinferior vena cava IVC or superior vena cava SVC, through the rightatrium RA, across the interatrial septum IAS and into the left atrium LAabove the mitral valve MV. As shown, a catheter 120 having a needle 122may be advanced from the inferior vena cava IVC into the right atriumRA. Once the catheter 120 reaches the interatrial septum IAS, the needle122 may be advanced so that it penetrates through the septum at thefossa ovalis FO or the foramen ovale into the left atrium LA. At thispoint, a guidewire may be advanced out of the needle 122 and thecatheter 120 withdrawn.

As shown in FIG. 40, access through the interatrial septum IAS willusually be maintained by the placement of a guide catheter 125,typically over a guidewire 124 which has been placed as described above.The guide catheter 125 affords subsequent access to permit introductionof the tool(s) which will be used for performing the valve or tissuemodification, as described in more detail below.

A typical retrograde approach to the mitral valve is depicted in FIG.41. Here the mitral valve MV may be accessed by an approach from theaortic arch AA, across the aortic valve AV, and into the left ventriclebelow the mitral valve MV. The aortic arch AA may be accessed through aconventional femoral artery access route, as well as through more directapproaches via the brachial artery, axillary artery, or a radial orcarotid artery. As shown in FIG. 42, such access may be achieved withthe use of a guidewire 128. Once in place, a guide catheter 126 may betracked over the guidewire 128. The guide catheter 126 affordssubsequent access to permit introduction of the tool(s) which will beused for performing the valve modification, as described in more detailbelow.

In some cases, access routes to the mitral valve may be established inboth antegrade and retrograde approach directions. This may be usefulwhen, for instance, grasping is performed with the use of specificdevices introduced through one route and fixation is achieved with theuse of separate devices introduced through another route. In onepossible situation, the transvalvular band may be introduced via aretrograde approach. While the transvalvular band is held in place, afixation tool may be introduced via an antegrade approach to fix thetransvalvular band in place. The access pathways for the transvalvularband and fixation tool may alternatively be reversed. Thus, a variety ofaccess routes may be used individually or in combination with themethods and devices of the present invention.

Referring to FIG. 43A, there is illustrated a schematic view of apercutaneously deliverable implant in accordance with one aspect of thepresent invention. The deployment system includes a deployment catheter200, only a distal end of which is illustrated herein. Deploymentcatheter 200 is configured in accordance with known technology foraccessing the mitral valve, utilizing conventional dimensions and thematerials known to those of skill in the art. In general, the deploymentcatheter 200 comprises an elongate flexible tubular body 202 extendingbetween a proximal end (not illustrated) and a distal end 204. Theproximal end is provided with a proximal manifold, including accessportals such as luer connectors in communication with each functionallumen in the catheter 200.

The distal end 204 is provided with a distally facing opening 208, whichis in communication with the proximal end via a central lumen 206.

Positioned within the central lumen 206 is a collapsed implant 210.Implant 210 is transformable between a first, radially reducedconfiguration such as for positioning within the deployment catheter 200and a second, radially enlarged configuration (see FIG. 43C) forpositioning at the treatment site. Transformation of the implant fromthe first configuration to the second configuration may be accomplishedunder positive force, such as via balloon dilatation. Alternatively, asillustrated herein, transformation is accomplished by self-expansion ofthe implant 210 in response to removal of the constraint provided by thetubular body 202.

In general, the implant 210 comprises a frame or anchor component 212and a leaflet support component 214. Leaflet support component 214 maycomprise any of a variety of structures similar to those describedpreviously herein as the annular band, configured or reconfigured suchthat the annular band may be radially reduced for positioning within adeployment catheter and subsequently radially enlarged for spanning themitral valve. The implant 210 additionally comprises an anchorcomponent, for anchoring the leaflet support 214 at the treatment site.In the illustrated embodiment, anchor 212 is schematically illustratedas a zigzag wire or filament structure, which is radially expansiblefollowing removal of the constraint. However, any of a variety ofconfigurations may be utilized for the anchor 212.

Referring to FIG. 43B, the outer tubular flexible body 202 is shownpartially retracted from the implant, permitting the implant to begin toradially expand. FIG. 43C illustrates further retraction of the tubularbody 202, to fully release the anchor 212 at the deployment site. Asillustrated, anchor 212 radially expands within the left atrium. Theleaflet support 214 extends approximately transversely to the coaptiveedge of the mitral valve leaflets, and is convex or inclined in thedirection of the mitral valve to advance the coaptation of the mitralvalve leaflets in the direction of the ventricle as has been describedelsewhere herein.

As seen in FIG. 43A, the implant 210 is controlled by at least onecontrol line 216. Control line 216 extends throughout the length of thedeployment catheter 200, and to at least one control on or near theproximal manifold. This enables proximal retraction of the flexible body202 with respect to the implant 210, and control of implant 210 prior tofinal detachment from the deployment system.

Referring to FIG. 43C, at least a first control wire 216, a secondcontrol wire 218, and a third control wire 220 are illustrated connectedto the anchor 212. Control wires 216, 218 and 220 enable manipulation ofthe implant into its final desired position, and, if necessary, proximalretraction of the implant back within the deployment catheter should thedecision be made to remove the implant prior to final detachment.

Prior to final detachment of the implant 210, additional anchoringstructures may be engaged to retain the implant at its desired implantedlocation. For example, anchor 212 may be provided with any of a varietyof tissue anchors or barbs, for engaging the mitral valve annulus or thebase of the leaflets or other adjacent anatomical structures.Alternatively, separate tissue anchors may be advanced through thedeployment catheter 200, and utilized to secure the anchor 212 to theadjacent tissue. Suitable anchors are preferably enlargeable from afirst, reduced cross sectional configuration for traveling through thedeployment catheter 200 and piercing tissue, to a second, enlargedconfiguration for resisting removal from the tissue. In the embodimentillustrated in FIG. 43C, no secondary anchoring structures areillustrated for simplicity.

Once the position of the implant 210 has been verified and foundacceptable, and the determination of whether to introduce secondaryanchoring structures has been made, the control wires 216, 218 and 220are detached from the anchor 212, and the deployment catheter 200 isremoved from the patient. Detachment of the control wires from theimplant 210 may be accomplished in any of a variety of ways, such as byelectrolytic detachment, detachment by thermal elevation of a softenableor meltable link, mechanical detachment such as by rotating the controlwire such that a threaded end of the control wire is threadablydisengaged from the anchor 212, or other detachment techniques dependingupon the desired functionality and profile of the system.

Referring to FIG. 43D, there is illustrated a side elevational view ofthe implant 210 in an unconstrained (e.g., bench top) expandedconfiguration. The anchor 210 comprises a plurality of struts 222, whichare joined at a first end by a plurality of apices 224 and a second endby a plurality of apices 226 to produce a zigzag structure sometimesreferred to as a “Z stent” configuration. This configuration isconvenient and well understood in the intravascular implant arts,although any wide variety of structures may be utilized. For example,zigzag wire patterns, woven wire patterns, or sinusoidal wire patternsmay be utilized. Laser cut wall patterns such as from tubing stock mayalso be utilized, and may be provided with any of a wide variety ofcomplex wall patterns. In general, nickel titanium alloys such as any ofa variety of nitinol alloys are preferred. However, depending upon thewall pattern, stainless steel, elgiloy, certain polymers or othermaterials may also be utilized. Heat treatment may be required to annealand shape set an alloy such as Nitinol. Other alloys may require onlyannealing to relieve stresses incurred during prior processing.

Referring to FIG. 43E, there is illustrated an end view of the implantshown in FIG. 43D to show the transverse configuration of thetransvalvular band portion of the implant. In this illustration, thetransvalvular band comprises a plurality of struts 230 which areconnected to the anchor 212 at junctions 232. Struts 230 may in turn bedivided into a bifurcated section 234 or other configuration to increasethe effective footprint of the transvalvular band measured along thecoaptive edge of the valve, while minimizing obstruction to blood flowtherethrough. The coaptive edge of the valve, as implanted, willpreferably be approximately aligned with the transverse axis 236illustrated in FIG. 43E of the band, as implanted. The axis of coaptionof the mitral valve is preferably parallel to axis 236 in the implantedconfiguration, but may be within about 45°, preferably within about 20°,and most preferably within about 10° of the axis 236.

Referring to FIGS. 44A and 44B, there is illustrated an anchordeployment catheter which may be utilized to provide either primary orsecondary anchoring of the anchor structure 212 to adjacent tissue.Anchor deployment catheter 250 comprises an elongate flexible tubularbody 252, configured to access the vicinity of the mitral valve. Tubularbody 252 extends between a proximal end 254 and a distal end 256. Distalend 256 is provided with a distal opening 258, enabling access to acentral lumen 260. An elongate flexible core wire 262 extends from theproximal end 254 throughout most of the length of the lumen 260 to adistal surface 264. See FIG. 44C. The proximal end of the core wire 262is provided with a control 266 that enables axial reciprocal movement ofthe core wire 262 within the central lumen 260.

A tissue anchor 268 may be positioned within the distal end of thedelivery catheter 250. In use, manipulation of the control 266, such asby distal axial advance relative to the tubular body 252, distally,axially advances the core wire 262 to expel the anchor 268 through thedistal opening 258. Distal opening 258 is preferably provided with abevel or angled cut to provide a sharpened distal tip 270. This enablesdistal axial advance of the distal tip 270 into tissue at a desiredsite, so that the control 266 may be manipulated to deploy all or aportion of the anchor 268 into the target tissue.

Any of a variety of tissue anchors 268 may be utilized, depending uponthe desired configuration of the implant and the implant anchorinterface. In the illustrated embodiment, the anchor 268 is configuredas a double “t-tag” anchor. A first tissue engaging element 272 isconnected to a second implant engaging element 274 by a filament 276. Inuse, the distal tip 270 is positioned within the tissue of the mitralvalve annulus. Control 266 is manipulated to deploy the first element272 beneath the surface of the tissue. The tubular body 252 isthereafter proximally retracted, enabling the second element 274 toengage the implant and retain it against the adjacent tissue.

The anchor delivery catheter 250 may be advanced through the deploymentcatheter 200, and/or along a guide such as a guidewire or support wire.In the illustrated embodiment, the anchor deployment catheter 250 isprovided with a guide lumen 278 allowing the anchor delivery catheter totrack along a guidewire. Guide lumen 278 is defined by a tubular wall280. Tubular wall 280 may extend the entire length of the anchordelivery catheter 250, such as by forming the catheter body as a duallumen extrusion. Alternatively, tubular wall 280 may be provided with anaxial length that is short relative to the overall length of thecatheter, such as no more than about 3 cm and preferably no more thanabout 2 cm in length. This allows the anchor delivery catheter to ridealong a guidewire in a monorail or rapid exchange manner as will beillustrated below.

Referring to FIGS. 45A and 45B, there is illustrated an implantconfigured for use with the anchor delivery catheter described above. Ingeneral, the implant comprises a first leaflet support 292 and a secondleaflet support 294, separated by a flexible connection 296. Flexibleconnection 296 permits the implant 290 to be folded within a deploymentcatheter, and later expanded in a manner that permits the implant 290 tofunction as a transvalvular band as described. The implant 290 may bemanufactured in any of a variety of ways, such as using a wire frame orby laser cutting from sheet stock as will be appreciated by those ofskill in the art.

In the illustrated embodiment, a first and second flexible connection296 reside in a plane configured to be substantially parallel to theaxis of coaption the as implanted orientation. The lateral edges of theeach of the first leaflet support 292 and second leaflet support 294 areprovided with at least one and preferably two or three eyes 298, fabricpatches, or other anchor attachment structure, for receiving a tissueanchor.

Referring to FIG. 45B, the implant of FIG. 45A is illustrated in apartially collapsed configuration, flexed about the flexible connection296. In addition, control wires 300, 302 and 304 are illustratedreleasably connected to the implant 290. Control wires 300, 302 and 304may be utilized to advance the implant 290 from the deployment cathetersuch as catheter 200 described above, and manipulate the implant untilthe anchors have been fully deployed. Thereafter, control wires 300, 302and 304 may be removed such as by electrolytic detachment, melting apolymeric link, unscrewing a threaded connection, or other detachmentmechanism depending upon the desired functionality of the device.

Referring to FIGS. 46A through 46E, there is illustrated a sequence ofdeploying an implant at the mitral valve from an antegrade direction.The implant 290 may be similar to that illustrated in FIGS. 45A and 45B,or have wall patterns or characteristics of other implants disclosedelsewhere herein. In general, the implant 290 is deployed from thecatheter 200 in the sequence illustrated in FIGS. 46A through 46C. Thesurrounding anatomy has been eliminated for simplicity.

Referring to FIG. 46D, the anchor delivery catheter 250 is advanced ontothe proximal end of one of the control wires 300, such that the controlwire 300 is axially moveably positioned within guide lumen 278. Thisenables the anchor delivery catheter 250 to be advanced along thecontrol wire 300 in a monorail or rapid exchange configuration as isunderstood in the catheter arts. Anchor delivery catheter 250 isadvanced along the control wire 300 until the distal tip 270 advancesthrough the eye 298 or fabric tab or other attachment structure, andinto the adjacent tissue of the base of the mitral valve leaflet ormitral valve annulus. The control 266 is manipulated such as by distaladvance to advance the first anchor element 272 out of the distalopening 258 and into the tissue as illustrated in FIG. 46D.

The anchor delivery catheter 250 is thereafter proximally withdrawn toposition the distal opening 258 on the device proximal side of the eye298, and the core wire 262 is further distally advanced to deploy thesecond anchor element 274 from the distal opening 258 of the anchordelivery catheter 250. Anchor delivery catheter 250 may thereafter beproximally withdrawn from the patient. Either the same or a differentanchor delivery catheter 250 may thereafter be advanced along the thirdcontrol wire 304, enabling deployment of another tissue anchor as isillustrated in FIG. 46E.

The implant 290 is illustrated in FIG. 46E as having a central portioninclined in the direction of the ventricle to support the leaflets ashas been discussed elsewhere herein. This configuration may be retainedby the inherent bias built into the structure and materials of theimplant 290. Alternatively, the configuration of inclining in thedirection of the ventricle may be retained by active intervention suchas by providing a mechanical interlock, in situ heat weld withcapacitive discharge/electrolytic weld, application of a clip or otherlocking structure by way of control wire 302 or simply by the mechanicalforces attributable to the mitral valve annulus, which prohibit lateralexpansion of the device sufficient for the flexible connection 296 toinvert in the direction of the atrium. Alternatively, an implantablecontrol wire (not illustrated) may be introduced, to connect the implant290 such as in the vicinity of the flexible connection 296 to theopposing wall of the ventricle, as will be described in connection witha transapical implementation of the invention described below.

A further implementation of the invention is illustrated in connectionwith FIGS. 47A through 47E. Referring to FIG. 47A, the first controlline 300 and third control line 304 have been replaced by a first guidetube 310 and a second guide tube 312. First guide tube 310 and secondguide tube 312 each has the double function of controlling deployment ofthe implant, as well as enabling introduction of a tissue anchortherethrough. This avoids the use of a separate tissue anchor deploymentcatheter such as that described above.

As illustrated in FIG. 47B, once the implant is provisionally positionedin the vicinity of the mitral valve, a first tissue anchor 314 isdeployed through the first guide tube 310. A second tissue anchor 316 isdeployed through the second guide tube 312. The tissue anchors maycomprise “T” tag type constructions, pigtail or corkscrew constructions,or any of a variety of other soft tissue anchors known in the art. Ingeneral, tissue anchors utilized for the present purpose are preferablytransformable from a first, reduced cross-sectional configuration to asecond, radially enlarged cross-sectional configuration to enabledeployment through a small needle or tube and then provide a relativelyhigher resistance to pull out. Radial enlargement may be accomplished byangular movement of a portion of the anchor, or by physical expansion ina radial direction.

Referring to FIG. 47C, the first guide tube 310 and second guide tube312 have been removed following deployment of the tissue anchors. Theguide tubes may be removed using any of a variety of detachmenttechniques disclosed elsewhere herein. Either before or after removal ofthe guide tubes, distal pressure on either the tubular body 202 or thecontrol wire 302 inverts the implant from the configuration shown inFIG. 47C to the final configuration shown in FIGS. 47D and E. Theinverted configuration of FIGS. 47D and E may be retained by themechanical bias imparted through the anchoring to the mitral valveannulus, or using techniques described elsewhere herein. The controlwire 300 is thereafter detached from the implant, as illustrated in FIG.47E.

Any of a variety of the implants of the present invention mayalternatively be introduced across the ventricle, such as in atransapical approach. The retrograde approach to the mitral valve willnecessitate certain modifications to both the implant and the deploymentsystem, as will be appreciated by those of skill in the art in view ofthe disclosure herein.

For example, a transventricular approach is illustrated in FIGS. 48Athrough 48D. A deployment catheter 320 is introduced into the ventricle,and retrograde through the mitral valve to position the distal opening208 within the atrium. An implant is carried within the deploymentcatheter 320, as has been described elsewhere herein. In general, theimplant comprises a first leaflet support 292 and a second leafletsupport 294 separated by a flexible zone or pivot point.

In the retrograde implementation of the invention, the first and secondleaflet supports are flexible or pivotable with respect to thelongitudinal axis of the control wire 300, such that they may be movedbetween a first configuration in which there are substantially parallelwith the axis of the control wire 300, and a second position, asillustrated in FIGS. 48A through 48D, in which they are inclinedradially outwardly from the longitudinal axis of the control wire 300 inthe device proximal direction. The implant may thus reside within thedeployment catheter 320 when the first leaflet support 292 and secondleaflet support 294 are in the first, reduced crossing profileconfiguration, with each of the tissue anchors 314 and 316 pointing in adevice proximal direction. In this embodiment, the tissue anchor 314 maybe permanently affixed to or integral with the first leaflet support 292and the second anchor 316 may be similarly carried by the second leafletsupport 294.

Once the distal end of the deployment catheter 320 has been positionedwithin the atrium, the control wire 300 may be distally advanced toadvance the anchors 314 and 316 beyond the distal opening 208. Thisreleases the implant and allows the angle between the first and secondleaflet supports to be increased, so that the tissue anchors 314 and 316may be aimed at the desired tissue anchor target sites. Proximalretraction on the control wire 300 may be utilized to seat the tissueanchors within the target tissue, as illustrated in FIG. 48B.

Further proximal traction on the control wire 300 may be utilized toinvert the implant into the configuration illustrated in FIG. 48C. Atthat point, the control wire 300 may be severed from the implant as hasbeen discussed elsewhere herein. Alternatively, the deployment catheter320 may be proximally retracted leaving the control wire 300 secured tothe implant, and a second portion of the control wire may be secured toa tissue anchor 322 within or on the epicardial surface of theventricle. Anchor 322 may comprise any of a variety of structures, suchas a pledget, button, or other structure that provides a footprintagainst the epicardial surface to resist retraction of the control wire300 into the ventricle. The control wire 300 may thereafter be severedproximally of its securement to the anchor 322, leaving the control wire300 and anchor 322 in position to span the ventricle and retain theconfiguration of the implant as illustrated in FIG. 48D.

In all the foregoing embodiments, the final configuration of the implantwithin the mitral valve is illustrated in a highly schematic form, andthe angle and degree of inclination into the direction of the ventriclemay be significantly greater than that illustrated herein depending uponthe desired clinical performance. The transvalvular band inclination canbe highly advantageous in some embodiments in providing clinical benefitas it facilitates “physiologic coaptation” in a preferred manner as itssurface mimics the three dimensional feature created by the leaflets asthey would have coapted in a healthy native valve.

Referring to FIGS. 49A through 49H, there is illustrated a transapicalapproach to the mitral valve, and deployment of a transvalvular band inaccordance with the present invention. As illustrated in FIG. 49A, adeployment catheter 320 has been introduced such as via thoracotomy, andadvanced retrograde through the mitral valve. A transvalvular band 324has been deployed distally from the catheter 320, and is illustrated inFIG. 49A in an expanded configuration within the left atrium. Expansionof the transvalvular band 324 from a reduced cross-sectional profile forpositioning within the catheter 320 to the enlarged cross-sectionalprofile illustrated in FIG. 49A may be accomplished either undermechanical force, such as by dilatation of an inflatable balloon orother mechanical mechanism. Preferably, however, transvalvular band 324is self-expandable so that it converts from the reduced profile to theenlarged profile automatically upon deployment from the distal end ofthe catheter 320.

In the illustrated embodiment, the transvalvular band 324 comprises anarcuate central portion 325, which is convex in the direction of theventricle. See FIGS. 49A and 49B. The transvalvular band 324 is providedwith a first attachment structure 326 and a second attachment structure328. Attachment structures 326 and 328 may comprise any of a variety ofstructures disclosed herein, such as tissue anchors, including hooks orbarbs. In one implementation of the invention, the first attachmentstructure 326, and second attachment structure 328 each comprise atarget for receiving an anchor as will be disclosed below. Suitabletargets for the present purpose include woven or non-woven fabrics,polymers, or other materials or constructions which permit a needle orsharpened anchor to penetrate therethrough, as will be discussed. In oneimplementation of the invention, each of the attachment structurescomprises a Dacron mesh, having a frame for supporting the mesh andsecuring the mesh to the transvalvular band 324.

Referring to FIG. 49B, there is illustrated a perspective view of thetransvalvular band 324 illustrated in FIG. 49A. The transvalvular band324 comprises a central section 325, convex in the direction of theventricle for affecting leaflet closure as has been described herein.Central section 325 is formed by a frame 327, which comprises at leastone strut 329 extending between the first attachment structure 326 andsecond attachment structure 328. In the illustrated embodiment, threestruts extend generally parallel to each other, defining at least twoelongate openings therebetween. One or two or four or more transverseelements 331 may be provided, such as to enhance structural integrity ofthe construct. At least a first control wire 300 and, optionally asecond or third or fourth control wire 300 is releasably attached to thetransvalvular band 324, to enable manipulation of the band into positionas shown in FIG. 49C. Control wire 300 is releasably connected to thetransvalvular band 324 at a connection point 301. The connection atpoint 301 may be established by threadable engagement, anelectrolytically detachable link or weld, or other detachment mechanism.Electrolytically detachable deployment systems are known, among otherplaces, in the neurovascular embolic coil and stent arts, and suitablesystems are disclosed in U.S. Pat. No. 5,976,131 to Guglielmi, et al.;U.S. Pat. No. 6,168,618 to Frantzen; and U.S. Pat. No. 6,468,266 toBashiri, et al., the disclosures of which are hereby incorporated intheir entireties herein by reference

The first attachment structure 326 comprises a support 333 carried bythe frame 327. In the illustrated embodiment, support 333 comprises anenclosed loop, having a central opening filled or covered by a mesh 337.The support 333 may alternatively comprise any of a variety ofstructures, such as a single linear element, sinusoidal or zigzagpattern, depending upon the desired performance. In the illustratedembodiment, the support 333 is conveniently provided in the form of aloop, to facilitate holding mesh 337 in a generally planarconfiguration, and support the mesh so that it may be punctured by ananchor, suture or other retention structure. A second support 335 issimilarly provided with a mesh 337, to facilitate attachment. The mesh337 may conveniently be a layer or pad of Dacron or other material, suchas an integration of a silicone core with a Dacron jacket, whichfacilitates both piercing by an attachment structure, as well as tissuein-growth for long term retention. The first support 333 and secondsupport 335 may comprise a radio opaque material, or be provided withradio opaque markers to enable aiming the anchor deployment system intothe mesh 337 under fluoroscopic visualization.

Once the transvalvular band 324 has been brought into the positionillustrated in FIG. 49C, the first attachment structure 326 and secondattachment structure 328 may be secured to the adjacent tissue using anyof a variety of clips, staples, barbs, sutures, or other structure whichmay be conveniently pierced through the mesh 337 and/or looped aroundthe first and second supports 333, 335. The retention element may beapproached from either the side of the left atrium, the ventricle, orepicardially, such as by way of a minimally invasive puncture on thechest wall. In the implementation of the method described below, theexample of advancing the retention elements from the left ventricle willbe described.

Referring to FIG. 49C, proximal traction on the catheter 320 and on thecontrol wire 300, pulls the transvalvular band 324 snuggly against theleft atrial side of the mitral valve, such that the first attachmentstructure 326 and second attachment structure 328 are seated against thevalve annulus.

Referring to FIG. 49D, a first anchor guide 330 and a second anchorguide 332 have been distally advanced from the distal end of thecatheter 320. Anchor guides 330 and 332 may be alternatively associatedwith or carried by the catheter 320 in a variety of ways. For example,the first and second anchor guides 330 and 332, may be pivotably carriedby the catheter 320, such that they may be inclined radially outwardlyfrom the longitudinal axis of the catheter in the distal direction.

In the illustrated embodiment, the first and second anchor guidescomprise a wire or tube for directing an anchor as will be discussed.The wire or tube of the anchor guide may comprise any of a variety ofmaterials, such as nickel titanium alloys (e.g. nitinol) which may bepreset to assume a position similar to that illustrated in FIG. 49D upondistal advance from the catheter 320. The first and second anchor guidesmay be provided with radio-opaque markers, or may be constructed from aradio-opaque material, to permit fluoroscopic guidance. In theillustrated embodiment, the first and second anchor guides are in theform of tubes, for axially slidably receiving a tissue anchor and tissueanchor deployment structures therein.

Referring to FIG. 49E, a retention element in the form of a first anchor334 is illustrated as having been distally advanced from the firstanchor guide 330, through the tissue in the vicinity of the mitral valveannulus, and through the first attachment structure 326. Penetration ofthe first anchor 334 through the first attachment structure 326 may beaccomplished while providing proximal traction on the control wire 300.

The first anchor 334 is provided with at least one and preferably two orfour or more transverse elements 336 to resist proximal retraction ofthe first anchor 334 back through the opening formed in the firstattachment structure 326. The transverse element or surface 336 may beprovided on any of a variety of structures, such as an umbrella-typestructure, t-tag, barbs, or other anchoring configuration which can passin a first direction through an opening formed in the first attachmentstructure 326, but resist retraction in a second, opposite direction,back through the first attachment structure 326.

The transverse element 336 is carried by a filament 338, which extendsthrough the adjacent myocardial tissue. Filament 338 may comprise any ofa variety of materials, such as a monofilament or multi-filamentstructure made from polypropylene, any of a variety of other knownsuture materials such as polyethylene, or metals such as stainlesssteel, nitinol, and others known in the art. The filament 338 may be amono-filament structure or a multi-filament structure which may bebraided or woven, depending upon the desired clinical performance. Atleast a second, similar anchor 340 is introduced on the opposing side ofthe mitral valve.

Referring to FIG. 49F, a second transverse element 342 is shown securedto or carried by the ventricular end of the filament 338, to provide asecure anchoring through the tissue wall for the transvalvular band. Asimilar structure is provided on the opposing side of the mitral valve.Although only a first and second anchoring systems has been describedabove, additional anchoring systems, such as a total of four or six oreight or more, typically in even numbers to produce bilateral symmetry,may be used. The number and configuration of tissue anchors will dependupon the configuration of the transvalvular band, as will be apparent tothose of skill in the art in view of the disclosure herein.

As shown in FIG. 49F, the anchors have been fully deployed and the firstanchor guide 330 and second anchor guide 332 have been proximallyretracted into the catheter 320.

Referring to FIG. 49G, the control wire 300 may thereafter be detachedfrom the transvalvular band and removed. Detachment of control wire 300may be accomplished in any of a variety of ways, as has been describedelsewhere herein.

Alternatively, the control wire 300 may be left in place as isillustrated in FIG. 49H. Control wire 300 is secured to an epicardialanchor 322, to provide a transventricular truss, as has been described.

Referring to FIGS. 50A and 50B, there is illustrated a side elevationalschematic view of the distal end of a deployment catheter 360 which maybe adapted for use in either the transapical delivery of FIGS. 49A-49H,or any other delivery mode described herein. In the illustratedembodiment, the deployment catheter 360 includes an elongate tubularbody having a central lumen 362, opening at a distal end 364. Carriedwithin the central lumen 362 is a transvalvular band 366, in a rolled-upconfiguration. Transvalvular band 366 is maintained in a rolled-upconfiguration by the constraint imposed by the deployment catheter 360.However, upon distal advance of the push element 368 to deploy thetransvalvular band 366 beyond the distal end 364, as illustrated in FIG.50B, the transvalvular band 366 unrolls under its natural bias into apredetermined configuration for implantation across the mitral valve.

One configuration for the transvalvular band is shown rolled out in planview in FIG. 51A. However, any of a variety of alternative transvalvularband configurations disclosed herein can be utilized with the catheterof FIGS. 50A and 50B.

Referring to FIG. 51A, there is illustrated a transvalvular band 366having a central portion 368 for spanning the coaptive edges of themitral valve. A first attachment zone 370 and a second attachment zone372 are provided on opposing ends of the central portion 368.

The central portion comprises at least a first strut 374 for spanningthe mitral valve as has been discussed. In the illustrated embodiment, asecond strut 376 and a third strut 378 are provided, spaced apart toincrease the width of the contact footprint with the valve leaflet butpermit blood flow therethrough. A first end of each of the struts 374,376, and 378 are connected at the first attachment zone 370, and thesecond ends of the three struts are connected at the second attachmentzone 372.

The first and second attachment zones may be provided with a reinforcingelement 382, to facilitate long term attachment. Apertures 380 areillustrated, which may be provided to allow manual suturing when thetransvalvular band 366 is intended for use in an open surgicalprocedure. Alternatively, apertures 380 may be configured for attachmentusing an anchor deployment catheter when intended for use in atranslumenal or transapical deployment. Each of the first, second andthird ribs may be provided with a central core, such as a nitinol orstainless steel wire or ribbon, and an outer coating such as apolycarbonate urethane with or without copolymers like silicone,silicone coating, or a fabric such as PET, ePTFE, polyethylene, or ahybrid of, for example, the aforementioned materials impregnatedsilicone coating, to reduce the risk of abrasion of the mitral valveleaflets A close-up view of circled zone 51D of FIG. 51A is illustratedin FIG. 51D.

FIG. 51D illustrates one embodiment of a fatigue-resistant terminalportion of a proximal and/or distal end of one, two, or more of thestruts 374, 376, 378 illustrated in FIG. 51D. The terminal portion 51Dmay have a non-linear portion 378′ and a head portion 379. Thenon-linear portion could be a coil with a helical, zig-zag, or any othergenerally non-linear shape to advantageously provide increased fatigueresistance for the struts. In some embodiments, at least a portion ofthe terminal portion 51D is embedded in an elastomer such as silicone,polycarbonate, urethane, or the like to further improve fatiguetolerance. In some embodiments, the terminal portion 51D may have astraight-line length that is less than 20%, 15%, 10%, 5%, or less of thestrut. In some embodiments, the terminal portion 51D may have astraight-line length that is at least about 5%, 10%, 15%, 20%, 25%, ormore of the length of the strut, or could even cover the entire lengthof one, two, or more struts 374, 376, 378 from first attachment zone 370to second attachment zone 372 (e.g., a strut without a linear portion).Head portion 379 is operably connected to non-linear portion 378′ andthe portions may be integrally formed. The head portion 379 could bespherical, ovoid, square, rectangular, triangular, or a variety of othershapes. Head portion 379 is in turn operably connected to firstattachment zone 370 and/or second attachment zone 372. In someembodiments, the head portion 379 is not attached to an attachment zonebut rather terminates as a free end of one or more of the struts 374,376, 378.

FIG. 51B is a side elevational view of the transvalvular band 366 ofFIG. 51A, shown in a flat configuration. However, as has been discussedelsewhere herein, the transvalvular band will typically be provided witha curvature such that it advances the mitral valve leaflets in thedirection of the ventricle and provides for physiologic coaptation.

FIG. 51C illustrates a perspective view of a transannular band 366 in arolled-up configuration for delivery, similar to that illustrated inFIG. 50B. The band can be rolled in a variety of ways, such as capturingthe band 366 at or near the center (near 363) and rolling it such thatboth ends are drawn inward as shown. In some embodiments, the band couldbe rolled up like a scroll, or folded into a “V”, “W”, or a variety ofother shapes. In some embodiments, at least a portion of the band 366resides within one or more slots 363 or movable jaw-like elements on thedistal end 363 of a mandrel 367 or other elongate body within a deliverycatheter. Actuation of the jaw-like elements to release the band 366,distal movement of a pusher tube, retraction of the mandrel 367 relativeto another catheter, or other mechanism can be employed to deploy theband 366. In some embodiments, turning the mandrel a desired distance,such as about 90 degrees, can help facilitate unfurling of the band 366for deployment.

Referring to FIGS. 52A-52C, there is illustrated a transvalvular band inaccordance with the present invention having a tissue attachment systemwhich may be adapted for either percutaneous or open surgical use. Thetransvalvular band comprises a central zone 368 carrying a firstattachment zone 370 and a second attachment zone 372 as has beendescribed.

A tissue anchor 390, such as a “t-tag” anchor includes a transverseelement 392 and an elongate flexible suture 394. As used herein, theterm “suture” is not limited to its normal definition, but also includesany of a wide variety of elongate flexible filaments, includingpolymeric, metal, combinations of both as well as monofilament andmultifilament structures. Multifilament structures may be braided,woven, or otherwise configured, depending upon the desired performance.

The suture 394 is illustrated to extend through a first guide 396 in thesecond attachment zone 372. For simplicity, only a single anchoringsystem will be disclosed herein. However, it should be appreciated thatthe anchoring system may be utilized on both ends of the central zone368, and more than one, such as two or three or more, anchors 390 may beutilized on each attachment zone.

The suture 394 is illustrated as extending through first guide 396, andthen through a lock 398 which will be described below. The free end 402of the suture 394 is further advanced through a second guide 400.Depending upon the intended use of the system, the free end 402 mayextend proximally throughout the length of the deployment catheter,where it may be manipulated such as by proximal traction in order totighten the second attachment zone 372 with respect to the transverseelement 392. Thereafter, the free end 402 may be severed in the vicinityof the second attachment zone 372 or elsewhere.

Referring to FIG. 52C, details of the lock 398 may be seen. In general,the lock 398 includes an aperture 404 through which the suture 394 mayextend. An engaging element 406 is exposed to the interior of theaperture, for permitting the suture to advance in a first directionthrough the aperture 404 but resist movement of the suture 394 in anopposite direction through the aperture 404. In the illustratedembodiment, the engaging element 406 is a sharpened point or spikeconfigured to mechanically pierce or engage the suture 394.

The foregoing structure permits the free end 402 to be proximallywithdrawn away from the second attachment zone 372 in a manner thatdraws the transverse element 392 closer to the second attachment zone372. However, traction on the transverse element 392 causes the suture394 to engage the engaging element 406, and prevents the transverseelement 392 from pulling away from the second attachment zone 372.

Referring to FIG. 52D, illustrated is a suture 394 which can be loopedthrough one, two, or more transverse elements 392 of anchors. The suture394 looped through the anchor can function as a pulley, whereappropriate traction on the suture 394 can tighten the anchors intoplace. Having a plurality of anchors as shown connected on one loop,such as, for example, 2, 3, 4, 5, or more anchors, can advantageouslyallow one cinching maneuver to tighten all of the anchors at once.

Referring back to FIG. 52A, an anchor deployment tool 408 isillustrated. Deployment tool 408 may comprise an elongate flexible wirehaving a proximal end 410 and a distal end 412. The deployment tool 408may extend throughout the length of a percutaneous translumenalcatheter, with the proximal end 410 exposed or attached to a control toallow axial reciprocal movement of the deployment tool 408. The distalend 412 is releasably positioned within an aperture 414 on a first endof the transverse element 392. A second end of the transverse element392 is provided with a sharpened point 416.

In use, distal axial advance of the deployment tool 408 is utilized todrive the transverse element 392 into a target tissue, to a desireddepth. Once the desired depth has been achieved, proximal retraction onthe deployment tool 408 proximally retracts the distal end 412 out ofthe aperture 414, allowing removal of the deployment tool 408 butleaving the transverse element 392 behind within the target tissue.Proximal traction on the free end 402 of the suture 394 enablestightening of the transvalvular band with respect to the transverseelement 392. Once a desired level of tightening has been achieved,releasing the free end 402 allows engaging element 406 to lock thesuture 394 against further release, thereby holding the transvalvularband into position.

Although the lock 398 is illustrated as an enclosed aperture,alternative lock embodiments may involve access from a lateral edge ofthe implant. This permits side-loading of the suture into the lock,which may in some instances be desired over an enclosed aperture whichrequires end loading of the suture through the aperture. A variety ofalternative side-loading lock configurations is illustrated in FIG. 53.

Referring to FIG. 54, there is illustrated a perspective view of analternate transvalvular band in accordance with the present invention.In this embodiment, the central section 368 is provided with anasymmetrical curvature, to provide asymmetrical support to the mitralvalve leaflets. Along the width or central portion of the transvalvularband, this provides a contour mimicking the three-dimensional shape ofthe coapted mitral valve in a healthy native valve, and provides aphysiologic analog thereby promoting correct anatomy during coaptation.

FIGS. 55 and 56 illustrate alternative transvalvular bands in accordancewith the present invention. In these embodiments, the attachment zonesare provided with tissue anchors configured to pierce the tissue of thevalve annulus. In general, the tissue anchors each comprise a pointedend, for penetrating tissue and a retention structure for resistingremoval of the tissue anchor from the tissue. The retention element inFIG. 55 is in the form of a first or second barb or shoulder, as will beunderstood by those skilled in the art. The retention feature of thetransvalvular band illustrated in FIG. 56 comprises an arcuateconfiguration for the tissue-piercing structure. Compression from theclosure of the valve leaflets against the convex side of the centralzone will tend to impart a circumferential force on the tissue anchors,advancing the distal point further in the direction of its own arcuatepath. This construction tends to allow the natural forces of closure ofthe mitral valve to increase the retention of the tissue anchor withinthe adjacent tissue. In some embodiments, the barbs can be used as aprimary anchor that can be crimped or otherwise secured in place. Inother embodiment, the barbs could act as positioning features, totemporarily hold the band in place while verifying the position. Theband could then be anchored in a secondary step, such as using a crimp,staple, suture, or other anchor as described herein. In someembodiments, the barbs can be self-locking upon penetration throughtissue.

In some embodiments, disclosed is a transvalvular band that providesresistance to coaptation in the same manner as the chordae providesresistance to coaptation in a continuously nonlinear fashion, like aviscoelastic response. This band could have a configuration such asdescribed and illustrated above, and could have material properties oradditional features to provide non-linear resistance to coaptation. Suchembodiments could retain a curvature mimicking the natural threedimensional surface of the coapted mitral valve yet could displace inthe retrograde direction up to the anatomically correct plane ofcoaption when appropriate. The direction of displacement, for example,with respect to the mitral valve is better described in the atrialdirection during systole to provide a cushioned impact for the valveleaflets as opposed to the leaflets striking a ridged implant structureand remodeling in a potentially deleterious fashion such as fibrosis orthinning around impact edges. FIG. 56A is reproduced from Nielsen et al,Circulation 2003; 108:486-491, Influence of Anterior Mitral LeafletSecond-Order Chordae Tendineae on Left Ventricular Systolic Function,which is hereby incorporated by reference in its entirety, illustratinga bilinear relationship between LV pressure and chordal tension duringisovolumic contraction, a decrease in chordal tension despite high LVpressure during ejection, and an almost linear decline during isovolumicrelaxation. FIG. 56B is reproduced from Nielsen et al, J ThoracCardiovasc Surg 2005; 129:525-31, Imbalanced chordal force distributioncauses acute ischemic mitral regurgitation: Mechanistic insights fromchordae tendineae force measurements in pigs, which is incorporated byreference in its entirety. These figures demonstrate that chordae forcewith respect to time increases and then decays in a non-linear mannerduring systole. A band mimicking this performance could benefit thevalvular surface as it returns its coaptive forces to a near normalstate. In some embodiments, a band could cushion or physiologicallyreduce or prevent physical stress caused by repetitive contact with thecoaptive leaflet surfaces. The band could accomplish this by virtue ofconstruction such as chambered struts that may or may not be filled witha media such as a fluid. These chambers would be enclosed andimpermeable or substantially impermeable to blood or blood componentpenetration within a lifetime. Another method of cushioned coaptionwould be a device that allows some flexing during coaption. Thisflexibility could be designed based upon strut material, thickness,width, inferior and superior cross-section such as a ripple, orencapsulation material such as an elastomer or elastomeric foam. Thefoam material could be sealed by an exterior polymer of equal overallflexibility. Additional embodiments would be coils (such as illustratedin FIG. 51D above) or coils within coils to produce unique nonlineardisplacement signatures or tubes such as Nitinol laser cut tubes thatcould optionally be filled with a polymer. Yet another embodiment wouldinclude struts that loop towards the ventricle crossing itself. Thisloop would also create this nonlinear resistance to coaption by itsspring force. In other embodiments, the band can proceed down to thechordae and devices can be adapted to shorten or augment the chordae toachieve natural physiology. Devices of this manner can be, for example,crimped bands with elastomer bodies between the crimped bands. Theelastomeric bodies would replicate the deficient portion of the chordaeto mimic the correct force curve during coaptation. This may provideenough benefit in some grades of the disease so as to provide palliativecare or resolve it.

FIGS. 57A-D illustrate another embodiment of a transvalvular band 500,which can also be referred to herein as a transvalvular bridge, e.g., amitral bridge. FIG. 57A is a perspective view of a transvalvular bridge500 according to some embodiments of the invention. The transvalvularbridge 500 can include a first attachment structure 504 at a first endof the bridge 500 and a second attachment structure 526 at a second endof the bridge 500, both attachment structures 504, 526 of which caninclude a variety of structures as discussed elsewhere herein foranchoring to the valve annulus. As illustrated, the attachmentstructures 504, 526 can have one or more layers 515 of a velour materialsuch as a Dacron mesh and having a underlying frame for supporting themesh and securing the mesh to the transvalvular band 500. The velourcould be 6111 Polyester Double Velour Fabric in some embodiments. Themesh material can advantageously promote tissue ingrowth in someembodiments. The attachment structures 504, 526 can also include one ora plurality of apertures 508 which can be configured to allow forsuturing therethrough, to attach the transvalvular bridge 500 to thevalve annulus.

Still referring to FIG. 57A, the transvalvular bridge 500 can alsoinclude an arcuate central portion 502 which can be generally convex inthe direction of the ventricle. As illustrated, the central portion 502can include a plurality of struts 516 that cross and form a generally“X” shape at intersection zone or junction 518. The struts 516 can bemade of any appropriate material, such as a metal, e.g., a shape memorymetal such as Nitinol. The struts 516 as well as the spaces 514 inbetween the struts 516 can be treated or coated, e.g., encapsulated withsilicone or another appropriate material as described elsewhere herein,in order to eliminate untoward effects such as thrombosis or corrosion.

FIG. 57B is a top view of the transvalvular bridge 500 of FIG. 57A. Asshown, the central portion 502 spans between the first attachmentportion 504 and the second attachment portion 526, and can have atransverse width laterally that is substantially the same as that of theattachment portions 504, 526, but can become narrower toward the centertoward intersection zone 518. In some embodiments, the width C in thecentral intersection zone 518 (measured perpendicular to blood flow) isbetween about 20% and about 80%, such as between about 25% and about50%, or about 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, or75% of the width of the central portion 502 just proximate to theattachment portions 504, 526, and can gradually narrow toward the centeras illustrated. In some embodiments, the width C in the centralintersection zone 518 can be between about 4 mm and about 7 mm, such asbetween about 5 mm and about 6 mm, or about 5 mm, about 5.2 mm, about5.4 mm, about 5.6 mm, about 5.8 mm, or about 6 mm, or rangesincorporating any of the foregoing values. By narrowing the centralportion 502, the resistance to blood flow can advantageously be reduced.

FIG. 57C is a side view of the transvalvular bridge 500 illustrated anddescribed in connection with FIGS. 57A-B. In some embodiments, thethickness T2 of the central portion 502 can be defined by the strut 516and the encapsulation layer 514 surrounding the strut. In someembodiments, the thickness T1 of the attachment portions 504, 526 can bedefined by the ends of the struts 516, an encapsulation layer 514surrounding the strut 516, and/or the velour material layer(s) 515 aspreviously described. The attachment portions 504, 526 can have arelatively greater thickness than the thickness of the central portion502. In some embodiments, the attachment portions 504, 526 can have athickness that is between about 25% and about 75% greater than that ofthe central portion 502, such as between about 40% and about 60%greater, or about 25%, 30%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, or 75%greater than the thickness of the central portion 502. In someembodiments, the central portion 502 can have a thickness T1 of betweenabout 0.5 mm and about 1.0 mm, such as about 0.6 mm, 0.7 mm, or 0.8 mm,or ranges incorporating any of the foregoing values. In someembodiments, the attachment portions 504, 526 can have a thickness ofbetween about 0.8 mm and about 1.3 mm, such as about 0.9 mm, 1.0 mm,1.05 mm, 1.07 mm, 1.1 mm, or 1.2 mm, or ranges incorporating any of theforegoing values.

Still referring to FIG. 57C, the transvalvular bridge 500 can have anentire axial length A in some embodiments of between about 15 mm andabout 40 mm, such as between about 20 mm and about 32 mm depending onthe patient's anatomy. The central portion 502 of the transvalvularbridge 500 can have an axial length in some embodiments of between about8 mm and about 24 mm, such as between about 12 mm and about 20 mm insome embodiments.

FIG. 57D illustrates an end view of the transvalvular bridge 500illustrated and described in connection with FIGS. 57A-C above, showingthe struts 516, silicone encapsulation layer 514, and attachment portion514. In some embodiments, the width W of the attachment structures 504,526 can be between about 10 mm and about 20 mm, and about 15 mm in someembodiments.

FIGS. 57E-H illustrate views of the underlying skeleton layer 560 of thetransvalvular bridge 500, and can be formed of a shape set Nitinolskeleton that can be convex in the direction of the ventricle aspreviously described. FIG. 57E is a perspective view of the shape memoryskeleton 560 of the transvalvular bridge 500, which can include struts516 that cross at intersection zone 518 as previously described. Thelateral ends of the skeleton 560 can include rings 509 definingapertures 508 that can be utilized for suturing as previously described.The skeleton layer 560 contribution to the central portion 502 of thetransvalvular band 500 can include lateral curved transition zone 521 ofthe struts 516, which has a first curvature; which is in turn connectedto medial curved transition zone 522 of the strut 516 which has a secondcurvature different from the first curvature; and the intersection zone518 which includes the vertex of the arcuate central portion 502. FIG.57F is a top view of the skeleton layer 560 of FIG. 57E. As illustrated,in some embodiments the lateral curved transition zones 521 of thestruts 516 can, while configured to slope downwardly as shown, can runsubstantially parallel to the longitudinal axis of the skeleton 560 (andthat of the transvalvular bridge 500), while the medial curvedtransition zone 522 can be oblique to the longitudinal axis of theskeleton 560 and the transvalvular bridge 500. In some embodiments, theaxial length CC of the skeleton layer 560 can be between about 13 mm andabout 25 mm, and the width BB of each strut 516 can be between about 1mm and about 2 mm, such as between about 1.3 mm and about 2.0 mm. FIG.57G is a side view, and FIG. 57H is an end view of the shape set Nitinolskeleton of FIGS. 57E-F.

As described above, the mitral valve and supporting structures arecomposed of the valve annulus, two leaflets, chordae tendineae, andpapillary muscles. The anterior and posterior leaflets, oriented in theseptal-lateral direction, provide for closing the valve opening duringsystole. During systole, the annulus and valvular surface create asaddle shape optimizing forces during closure by arching. The chordaeand papillary muscles work together to limit the leaflet coaptation tothe intraannular plane.

Qualitative Motion and Load on the Mitral Bridge: The mitral valve has asaddle shape. As the saddle gets deeper, the commissures drop, and theanteroposterior diameter contracts. This contraction results in acompressive load on the transvalvular bridge. During this contraction,the pressure behind the leaflets causes them to contact thetransvalvular bridge strut. In some embodiments, the mitral bridge isconfigured to withstand a total circumferential or compressive forceapplied to the Mitral Bridge of at about or at least about 0.35N, 0.40N,0.45N, 0.50N, or about 0.368N per cardiac cycle in some embodiments. Insome embodiments, the Mitral Bridge can be configured to tolerate aseptal-lateral displacement of about or at least about 0.4 mm, 0.5 mm,or 0.6 mm during the cardiac cycle. ⋅ As such, the mitral bridge can beconfigured to withstand load in cyclic fatigue without damage allowinglong term function; maintain an AP diameter or septal-lateral diameterfor early coaptation eliminating regurgitation; and/or maintain an APdiameter facilitating LV remodeling.

Quantitative Leaflet Loads: The force acting on a papillary muscle canbe, in some embodiments, between 3.97 and 6.42 N dependent upon systolicpressure typically ranging between 120 and 200 mmHg. There are twopapillary muscles. If both muscles were not functioning, the load actingon the mitral valve leaflets would be 13 N. The force transferred to themitral bridge can be calculated by using the ratio of the total orificearea to the area of the mitral bridge strut. The orifice and MB strutareas are typically 1000 mm² and 100 mm², respectively. The resultingload on the MB strut is about 1.3 N. This is the load that the mitralbridge would see if the chordate and papillary muscles were notabsorbing any load. Therefore, in some embodiments, the mitral bridgecan be configured to withstand a leaflet load of between about 1N andabout 2N, or about or at least about 1.2N, 1.3N, 1.4N, or 1.5N towithstand loads without damage, allowing for long-term function.

Quantitative Motion on the Mitral Bridge: Based upon a six month ChronicPorcine Study of the mitral bridge, the echo analysis of that studyshowed no perceptible displacement of device from the Septal-Lateral(SL) plane. However, in some embodiments the mitral bridge can beconfigured to tolerate a displacement of about 0.5 mm in compression andtension. The average force to displace a device ±0.5 mm is between about0.80N and about 0.85N, such as about 0.8358N in tension; and betweenabout 0.60N and about 0.70N, such as about 0.63808N in compression. Theforces found are over double the circumferential forces. The mitralbridge can be configured, when implanted, to withstand such forces andcontinue to stably function to improve valve coaptation without beingdamaged, displaced, or substantially displaced as noted above. Themitral bridge can thus be configured to tolerate, in some embodiments, atension force of about or at least about 0.75N, 0.80N, 0.85N, 0.90N,0.95N, 1.00N, or more. The mitral bridge can thus be configured totolerate, in some embodiments, a compression force of about or at leastabout 0.55N, 0.60N, 0.65N, 0.70N, 0.75N, 0.80N, or more.

FIGS. 58-70 illustrate a system of delivery catheters 600 configured foruse with the mitral devices described herein. While the system ofdelivery catheters 600 is described herein for use with thetransvalvular bridge 500, any of the mitral devices described herein canbe used with the devices and methods described herein. Referring back toFIG. 57A, the transvalvular bridge 500 comprises the first attachmentstructure 504 at the first end of the bridge 500 and the secondattachment structure 526 at the second end of the bridge 500. Thearcuate central portion 502 permits the transvalvular bridge 500 to befolded or otherwise compressed for delivery within a deploymentcatheter, and later expanded in a manner that permits the transvalvularbridge 500 to function as described. The attachment structures 504, 526can include one or a plurality of apertures 508 which can be configuredto allow for suturing therethrough, to attach the transvalvular bridge500 to the valve annulus. In the illustrated embodiment, each of theattachment structures 504, 526 comprises two apertures 508.

FIG. 58 illustrates features of the anatomy of the heart. A system ofcardiovascular catheters 600 is used to percutaneously deliver thetransvalvular bridge 500 to the mitral valve for the repair of themitral valve. The transvalvular bridge 500 can be securely attached tothe mitral valve annulus at four points, that is P1, P3, A1, and A3.Locations A1 and A3 can be located on the anterior leaflet. Locations P1and P3 can be located on the posterior leaflet. The locations P1, P3,A1, and A3 can correspond to the apertures 508 in the attachmentstructures 504, 526 of the transvalvular bridge 500. The transvalvularbridge 500 can be secured to provide coaptation of the mitral valveleaflets. The coaptation can be observable via various visualizationtechniques.

FIGS. 59A-59C illustrate features of the cardiovascular catheters 600.The cardiovascular catheters 600 described herein are intended fortranscatheter implantation of the transvalvular bridge 500. This methodis in contrast to an open-surgical implantation. An overview of thetranscatheter implantation of the transvalvular bridge 500 can includeone or more of the following steps. The patient can be anesthetized. Anintroducer catheter 602 can be introduced through the femoral vein. Theintroducer catheter 602 can be any commercially available introducercatheter. The method can include the step of inserting the introducercatheter 602. Imaging can be used throughout the procedure to ensureproper positioning. Imaging techniques can include fluoroscopy and2D/3D/4D TTE imaging modalities. In some methods of use, a guidecatheter 604 can be positioned in the right ventricle. In some methodsof use, the guide catheter 604 can be positioned in the right atrium.The guide catheter 604 can be 12F but other dimensions are contemplated.A septal needle 606 can be inserted through the guide catheter 604. Theseptal needle 606 can puncture through the atrial septum. The puncturecan be located at the 12 o'clock position, proximate the fossa ovalis.The guide catheter 604 can allow for subsequent dilation and advancementof the guide catheter 604. The guide catheter 604 can be advanced intothe left atrium.

The needle catheter 610 can be delivered through the guide catheter 604.The needle catheter 610 can include multiple components, as describedherein. The needle catheter 610 can be positioned to deliver a retainer612. The position for delivery may be located at approximately P3. Theneedle catheter 610 can deliver the retainer 612 via sub-annularpuncture. The needle catheter 610 can deliver the retainer 612 via apressure or force. The needle catheter 610 can deliver the retainer 612by applying electrical energy to create a hole. The hole can be createdin the annulus. The hole can be created in a leaflet. One or more holescan be created. The needle catheter 610 or a portion thereof can bepushed through the hole. The retainer 612 can be positioned anddelivered by being pushed from the needle catheter 610. The retainer 612can be deployed. The needle catheter 610 can be withdrawn. A suture tailof the retainer 612 can be left exteriorized through the venous access.The process can be repeated to deploy one or more additional retainers612. The additional retainers 612 can be placed at approximately P1, A1and A3. In some methods of use, two or more retainers 612 are deployedsimultaneously. In some methods of use, two or more holes are createdsimultaneously.

The transvalvular bridge 500 can be loaded into a deployment catheter614. The transvalvular bridge 500 can be crimped to fit within thedeployment catheter 614. The deployment catheter 614 can be deliverednear the annulus. The transvalvular bridge 500 can be deployed. Adilator 616 can be delivered through the deployment catheter 614. Thedilator 616 can allow for suture management and cinching.

The transvalvular bridge 500 can be secured by advancing a clip 620. Theclip 620 can be advanced via a pusher 622. The clip 620 can be advancedtoward the transvalvular bridge 500. The pusher 622 can extend throughthe deployment catheter 614. The suture can be trimmed via a trimmingcatheter 624. The trimming catheter 624 can extend through thedeployment catheter 614. The implantation of the transvalvular bridge500 can be viewed through imaging techniques. The cardiovascularcatheters 600 can be withdrawn. The incision can be closed.

In some embodiments, one or more catheter can be transseptal (TS)catheters. The transseptal catheters can include catheters delivered viathe atrial septum. The transseptal catheters can include the introducercatheter 602. The introducer catheter 602 can be a transfemoralintroducer. The transseptal catheters can include the guide catheter604. The transseptal catheters can include needle catheter 610. Thetransseptal catheters can include the deployment catheter 614. Thetransseptal catheters can include the dilator 616. The one or moretransseptal catheters can deploy on the atrial side of the mitral valve(in other words, upstream in the direction of blood flow of a cardiacvalve).

In some embodiments, the system 600 can include one or more transapical(TA) catheters. The transapical catheters can include an introducer 702.The transapical catheters can include a guide catheter 704. Thetransapical catheters can include an anvil delivery catheter 706. Thetransapical catheters can include a cinching catheter 708. The one ormore transapical catheters can deploy on the ventricular side of themitral valve (in other words, downstream in the direction of blood flowof a cardiac valve). The one or more transseptal catheters and the oneor more transapical catheters can deploy on opposite sides of theannulus. The deployment of the system 600 can be considered a hybridapproach.

FIG. 60 illustrates the locations of insertion for the one or moretransseptal catheters and the one or more transapical catheters. Themethod can include one or more of the following steps. The introducercatheter 602 can be inserted through a transfermoral approach. Theintroducer catheter 602 can be inserted through a transseptal approach.The introducer 702 can be inserted through a transapical approach. Theguide catheter 604 can be inserted through a transfermoral approach. Theguide catheter 604 can be inserted through a transseptal approach. Theguide catheter 704 can be inserted through a transapical approach. Thedeployment catheter 614 can be inserted through a transseptal approach.The anvil delivery catheter 706 can be inserted through a transapicalapproach. The needle catheter 610 can be inserted through a transseptalapproach. The cinching catheter 708 can be inserted through atransapical approach. The dilator 616 can be inserted through atransseptal approach.

The deployment of the sutures can be through a transseptal approach. Thesuture retrieval can be through a transapical approach. The suture countand management can be through a transapical approach. The cinching canbe through a transapical approach. The deployment of the transvalvularbridge 500 can be through a transseptal approach. The knotting can bethrough a transapical approach. The suture can be cut through atransapical approach. The withdrawal of the one or more catheters can bethrough a transseptal approach. The withdrawal of the one or morecatheters can be through a transapical approach. The closure can bethrough a transapical approach and/or through a transseptal approach.

In some embodiments, the delivery is through a singular location. Themethod can include delivery of the one or more transseptal catheters.The introducer catheter 602 can be inserted at described herein. Theguide catheter 604 can be inserted as described herein. In the atrium,the needle catheter 610 can be deployed. In the atrium, the deploymentcatheter 614 can be deployed. In the subvalvular region, the anvildelivery catheter 706 can be deployed. In the subvalvular region, thecinching catheter 708 can be deployed. The anvil delivery catheter 706can be inserted transaortically. The anvil delivery catheter 706 can beinserted through a transmitral approach via transseptal access.

FIGS. 61A-61G illustrates an example of the hybrid approach. FIG. 61Ashows an embodiment of transseptal (TS) catheters. The guide catheter604 is shown as a sheath. The deployment catheter 614 extend through theguide catheter 604 to the atrium to deploy the transvalvular bridge 500.The needle catheter 610 can extend through the guide catheter 604 to theatrium. Referring to FIG. 61B, the needle catheter 610 can deploy one ormore needles 628. In the illustrated embodiment, the needle catheter 610deploys three needles 628. In some embodiments, three retainers 612 aredeployed by the three needles 628. In some embodiments, six retainers612 are deployed (e.g., two sets of three retainers 612). In someembodiments, the needle catheter 610 deploys six needles 628. The sixneedles 628 can correspond to six retainers 612.

The deployment catheter 614 can include a port 640. The port 640 canallow deployment of the transvalvular bridge 500. The transvalvularbridge 500 can exit the deployment catheter 614 through the port 640.The port 640 can be located on a side surface of the deployment catheter614. The retainers 612 can be coupled to the transvalvular bridge 500prior to deployment of the transvalvular bridge 500. In someembodiments, a suture 654 of the retainer 612 extends through anaperture 508 of the transvalvular bridge 500. In some embodiments, twoor more sutures corresponding to two or more retainers are coupled tothe transvalvular bridge 500 prior to deployment.

The one or more needles 628 can be designed to interact with an anvil710. The anvil 710 can be delivered to a sub annular location via theanvil delivery catheter 706. The anvil 710 can include one or more slots712. In some embodiments, the number of slots 712 can correspond to thenumber of needles 628. In the illustrated embodiment, the anvil 710includes three slots 712. The slot 712 can be sized and shaped to acceptthe needle 628 therethrough. The needle 628 can extend through the anvil710 in a direction transverse to the longitudinal axis 714 of the anvil710.

The anvil 710 is designed to be deployed to support the annulus. Theanvil 710 can have a first configuration wherein the longitudinal axis714 of the anvil 710 is generally parallel to a longitudinal axis of theanvil delivery catheter 706. The longitudinal axis 714 of the anvil 710can be coaxial with the longitudinal axis of the anvil delivery catheter706. The first configuration can be a low profile configuration. Theanvil 710 can be deployed within the left ventricle. The anvil 710 canbe pivoted. The anvil 710 can have a second configuration wherein thelongitudinal axis 714 of the anvil 710 is generally perpendicular to alongitudinal axis of the anvil delivery catheter 706. The anvil 710 canlie against the annulus. The anvil 710 can support the annulus. The slot712 of the anvil 710 can be in position to accept the needle 628. Thesecond configuration can be a deployed configuration. The anvil 710 caninclude a lock 716. The lock 716 can maintain the position of the anvil710 in the second configuration. The lock 716 can maintain the positionof the anvil 710 relative to a control arm 718. The anvil 710 can behinged relative to the control arm 718. In some embodiments, the controlarm 718 is rigid. In some embodiments, the control arm 718 is flexible.The angle between the anvil 710 and the control arm 718 can beapproximately ninety degrees. Other configurations are contemplated(e.g., 30 degrees, 40 degrees, 50 degrees, 60 degrees, 70 degrees, 80degrees, 90 degrees, 100 degrees, 110 degrees, 120 degrees, etc.). Theanvil 710 can lock at 290 degrees.

As described herein, the retainer 612 can be loaded into the needle 628.The retainer 612 can include a pledget 652. The retainer 612 can includethe suture 654. The needle can deliver the retainer 612 through the slot712 in the anvil 710. The retainer 612 can be considered an uncrimpedsuture tag. The retainer 612 can include a suture pinch point.

FIG. 61C illustrates the trajectory of the needle 628. In someembodiments, the one or more needles 628 extend along a straight paththrough the needle catheter 610. In some embodiments, the one or moreneedles 628 extend in a straight path from the needle catheter 610. Thetrajectory of the needle 628 can be linear. In some embodiments, the oneor more needles 628 extend along a non-linear, curved or helical paththrough the needle catheter 610. In some embodiments, the one or moreneedles 628 extend in non-linear path from the needle catheter 610. Thetrajectory of the needle 628 can be non-linear. As described herein, theneedle catheter 610 can be steerable. The needle catheter 610 can curve.The curvature of the needle catheter 610 can align the trajectory of theone or more needles 628 with the slots 712 in the anvil 710. In someembodiments, two or more needles 628 are designed to be simultaneouslyinserted into two or more slots 712. In some embodiments, two or moreneedles 628 are designed to deliver retainers 712 simultaneously throughtwo or more slots 712.

FIGS. 61D and 61E illustrates a method of using the anvil 710. The anvil710 can be moved into position relative to the annulus. The anvil 710can be pivoted relative to the control arm 718. The anvil 710 can belocked relative to the control arm 718. In the locked configuration, theanvil 710 supports a larger cross-section of the annulus. The needle 628can be aligned with the slot 712 of the anvil 710. The retainer 612 canbe disposed within the needle 628. The suture 654 of the retainer 612can be coupled to the transvalvular bridge 500. The suture 654 can spanfrom the needle catheter 610 to the transvalvular bridge 500. A plunger656 can be disposed within the needle catheter 610. The anvil 710 can beheld in position via the lock 716 during delivery of the retainers 612.

The needle 628 can be advanced to puncture the annulus, as describedherein. The needle 628 can be advanced such that the needle 628 burns ahole in the annulus, as described herein. The needle 628 can be advancedthrough the slot 712 of the anvil 710. The needle 628 can deliver theretainer 612 through the annulus. The plunger 656 can be advanced topush the retainer 612 through the needle 628. The plunger 656 can causethe retainer 612 to enter the left ventricle. The retainer 612 can besubannular. The suture 654 of the retainer 612 can span from theretainer 612 to the transvalvular bridge 500. The suture 654 of theretainer 612 can span the annulus from the left ventricle to the leftatrium.

FIG. 61F illustrates the cinching catheter 708. The transvalvular bridge500 can be deployed and positioned relative to the annulus. As describedherein, the transvalvular bridge 500 can be coupled to the suture 654 ofthe retainer 612. The suture 654 can extend through the annulus from thepledget 652. The anvil 710 can separate the pledget 652 from the annulusafter the retainer 612 is deployed. The anvil 710 can be retracted intothe anvil delivery catheter 706. The anvil 710 causes the pledget 652 tomove toward the anvil delivery catheter 706. The cinching catheter 708can cause the anvil delivery catheter 706 to move inward. In theillustrated embodiment, the cinching catheter 708 controls two anvildelivery catheters 706. The cinching catheter 708 can cause the twoanvil delivery catheters 706 to move toward each other. The cinchingcatheter 708 can cause the two anvil delivery catheters 706 to becomemore linear or straighter. The cinching catheter 708 can cause thetransvalvular bridge 500 to be cinched. The cinching catheter 708 cancause the transvalvular bridge 500 to be cinched. The cinching catheter708 can cause the attachment structures 504, 526 of the transvalvularbridge 500 to move toward each other.

FIG. 61G illustrates a method. The method can include one or more of thefollowing steps. The method can include the step of holding all of thesutures 654. The anvil 710 can enable one or more retainers 612 to beheld. In the illustrated embodiment, three retainers 612 are held by theanvil 710. The method can include withdrawal of the anvil 710. The anvil710 can be retracted into the anvil delivery catheter 706. The methodcan include withdrawal of the anvil delivery catheter 706. The anvildelivery catheter 706 can be withdrawn into the cinching catheter 708.The method can include removal of the pledget 652 or tag. The pledget652 can be removed while the suture 654 is held in position. In somemethods of use, the suture 654 is held in tension from the ventricularside of the annulus. In some methods of use, the suture 654 is held intension from the atrial side of the annulus. The method can includeloading a suture fastening system such as a COR-KNOT device (LSISolutions, Inc., Victor, N.Y.). The method can include loading apledget. The method can including cinching. The cinching can applytension to the transvalvular bridge 500. The cinching can apply tensionto the pledget 652. The cinching can apply tension to the suture 654.The cinching can apply tension to the anvil 712. The cinching can moveone or more components of the system into position. The method caninclude deploying the suture fastening system.

FIG. 62 illustrates the needle catheter 610. The needle catheter 610 caninclude the needle 628. The illustrated embodiment includes two needles628 but other configurations are contemplated (e.g., one needle, twoneedles, three needles, four needles, five needles, six needles, etc.).The two needles 628 can be similar or identical. The two needles 628 canbe oriented to be a mirror image. The needle 628 can be designed forpuncturing the annulus. The needle 628 can include a sharpened tip 630.The sharpened tip 630 can be any design to allow for puncture. In theillustrated embodiment, the sharpened tip 630 is tapered from an insidesurface to an outside surface. The needle 628 can be cylindrical. Theneedle 628 can include a lumen 632. In some embodiments, thetransvalvular bridge 500 can be disposed within the needle catheter 610.In some embodiments, the transvalvular bridge 500 can be designed tospan the distance from between the needles 628. In some embodiments, thetransvalvular bridge 500 can be designed to be deployed by advancingthrough the end of the needles 628.

The needle catheter 610 can use fluid pressure to deliver the needle628. In some methods of use, the needle catheter 610 can allow forhydraulic or compressed air delivery of the needle 628. The needlecatheter 610 can include a flexible pressure vessel 634. The flexiblepressure vessel 634 can include a fluid chamber. The fluid can be gas orliquid. The fluid can be air. The flexible pressure vessel 634 can beflexible to enable the needle catheter 610 to flex or turn. The flexiblepressure vessel 634 can allow components to apply a pressure or force onother components within the needle catheter 610. The needle catheter 610can include a pressure plate 636 for an internal pusher or plunger. Thepressure plate 636 allows a pressure or force to be applied to theinternal pusher or plunger. For instance, a pressure or force can beapplied to move the retainer 612. For instance, a pressure or force canbe applied to move the transvalvular bridge 500. The needle catheter 610can include a pressure plate 638 for the needle 628. The pressure plate638 can allow a pressure or force to be applied to the needle 628. Forinstance, a pressure or force can be applied for sub-annular puncture.The needle catheter 610 can include a catheter port 640. The catheterport 640 can allow the flexible pressure vessel 634 to be filled withfluid.

FIGS. 63A and 63B illustrate perspective views of the needle 628. Theneedle 628 can include an energy tip 644. The energy tip 644 candelivery energy such as RF energy to the tissue. The energy tip 644 canbe an electrode. The energy tip 644 can be coupled to the needle 628.The energy tip 644 can be integrally formed with the needle 628. Theenergy tip 644 can be located within a detent 646 of the needle 628. Thedetent 646 can enable the energy tip 644 to be partially or entirelydisposed within the detent 646. The detent 646 can change thecross-sectional shape of the lumen 632 as shown in FIG. 60B. The energytip 644 can be designed to burn through the annulus. The energy tip 644can be designed to the puncture through the annulus. The energy tip 644can be located at the distalmost edge of the needle 628. The energy tip644 can protrude past the distalmost edge of the needle 628 such thatthe energy tip 644 is the first to contact the annulus. The needle 628can include a slot 648.

FIG. 63C illustrate various additional views of the needle 628.Referring to FIG. 60C, the energy tip 644 can be a sleeve. The energytip 644 can partially surround the needle 628. The energy tip 644 can becoupled to an energy source (not shown). The energy source can supplythe energy tip 644 with energy such as electrical energy. The energy tip644 can convert the electric energy to RF energy. The energy tip 644 canenable RF heating. The energy tip 644 can enable the application of ahigh-frequency or radiofrequency electric current to biological tissuesuch as the annulus. The energy tip 644 can allow the tissue to be cut.The energy tip 644 can also coagulate blood or blood vessels orcauterize the tissue. The needle catheter 610 can include a sheath (notshown) which covers the needles 628 during delivery. The sheath cancover the energy tip 644.

In some methods of use, the user locates the position and uses low forcefor penetration of the needle 628. In some methods of use, the energytip 644 can be a guide for the incising needle 628. The energy tip 644can be collinear with the needle 628. The initial penetration can bewith the energy tip 644. The secondary penetration can be with theneedle 628. The energy tip 644 can be co-linear with the needle catheter610. The energy tip 644 can be co-axial with the needle catheter 610. Insome embodiments, suction is used to locate and provide puncturecounterforce.

FIGS. 64A and 64B illustrate the deployment of the retainer 612. Theretainer 612 can include the pledget 652. The pledget 652 can becylindrical or any shape known in the art (rectangular, square, oval,elliptical, etc.). The pledget 652 can be shaped to be disposed withinthe lumen 632 of the needle 628. The pledget 652 can be formed from aplastic or polymer materials. The pledget 652 can comprisepolytetrafluorethylene (PTFE). The pledget 652 can be sterile andnon-absorbable. The retainer 612 can include the suture 654. The pledget652 can be coupled the suture 654. The suture 654 can be formed from aplastic or polymer materials. The suture 654 can comprise polyethyleneterephthalate (PET). The suture 654 can be any size known in the art. Inthe illustrated embodiments, the suture 654 is size 2 (2-0). Theretainer 612 can secure the transvalvular bridge 500 in the annulus. Theretainer 612 can be used to replicate open implants. The retainer 612can be disposed within the needle catheter 610. The retainer 612 can bea self-locking slice for single column. The retainer 612 can be doublelocked by the clip 620. The retainer 612 can hold the transvalvularbridge 500 in place. The retainer 612 can hold greater than the suturestrength in the annulus.

Referring to FIG. 64A, the retainer 612 can be loaded into the lumen 632of the needle 628. The suture 654 can be attached to the pledget 652before being loaded into the needle 628. The retainer 612 can bedisposed in a first orientation. In the first orientation, the pledget652 of the retainer 612 can have a longitudinal axis aligned with thelongitudinal axis of the lumen 632 of the needle 628. The suture 654 canextend from the distal end of the needle 628. The suture 654 can extendthrough the slot 648 of the needle 628. The suture 654 can extend towardthe proximal end of the needle 628. The suture 654 can be held withinthe needle catheter 610 during delivery. The retainer 612 can bedisposed in the needle 628 during delivery through the annulus.

In the first orientation, the pledget 652 of the retainer 612 can have alongitudinal axis aligned with the longitudinal axis of the hole createdby the needle 628. As described herein, the energy tip 644 can burn ahole in the annulus. The needle 628 can enlarge the hole created by theenergy tip. The needle 628 can puncture the annulus. The needle 628 canbe delivered through the hole. The retainer 612 can be delivered throughthe hole created by the energy tip 644. The retainer 612 can bedelivered through the hole created by the needle 628.

Referring to FIG. 64B, the retainer 612 can be deployed. The needlecatheter 610 can include the plunger 656. The plunger 656 can beadvanced along the lumen 632 of the needle 628. The plunger can push theretainer 612 out of the needle 628. The pledget 652 of the retainer 612can be plunged out of the needle 628. The pledget 652 can be disposed onthe other side of the annulus. The suture 654 of the retainer 612 canspan the annulus. The retainer 612 can be disposed in a secondorientation. In the second orientation, the pledget 652 of the retainer612 has a longitudinal axis not aligned with the longitudinal axis ofthe lumen 632 of the needle 628. In some methods of use, thelongitudinal axis of the pledget 652 is ninety degrees from thelongitudinal axis of the lumen 632 of the needle 628. In some methods ofuse, the longitudinal axis of the pledget 652 is transverse to thelongitudinal axis of the lumen 632 of the needle 628. In some methods ofuse, the pledget 652 is rotated during deployment. The needle catheter610 can be withdrawn after deployment of the retainer 612. Referringback to FIG. 60, the pressure plate 636 allows a pressure or force to beapplied to the plunger 656. The pressure plate 636 can enable theplunger 656 to deploy the retainer 612.

Referring to FIG. 62, the needle catheter 610 can deliver two retainers612. In some methods of use, the needle catheter 610 can be moved toanother location. The needle catheter 610 can deliver two additionalretainers 612. In some methods of use, the needle catheter 610 candeliver four retainers 612. The needle catheter 610 can create thenumber of holes corresponding to the number of apertures 508 of thetransvalvular bridge 500. In the illustrated embodiment, the needlecatheter 610 can create four holes corresponding to the four apertures508 of the transvalvular bridge 500. After the retainers 612 aredeployed, four sutures 654 can span the annulus.

FIG. 64C-64E show a single needle catheter 658. The single needlecatheter 658 can include any of the features of needle catheter 610. Thesingle needle catheter 658 can include the needle 628. The needle 628can include the sharpened tip 630. The needle 628 can include the lumen632. The single needle catheter 658 can include the energy tip 644. Theneedle 628 can include the detent 646. Referring to FIG. 64D, the singleneedle catheter 658 can be designed to deliver the retainer 612. Thesingle needle catheter 658 can deliver one retainer 612. The singleneedle catheter 658 can include the plunger 656. The plunger 656 canextend through the lumen 632 of the needle 628 to deploy the retainer612. FIG. 64E shows various components decoupled.

FIG. 65A-65G illustrate the deployment of the transvalvular bridge 500.The transvalvular bridge 500 can be deployed via the deployment catheter614. In some embodiments, the transvalvular bridge 500 can include anasymmetric feature to wrap the transvalvular bridge 500 around with asheath. The transvalvular bridge 500 can be cinched to reduce diameter.The transvalvular bridge 500 can be folded within the deploymentcatheter 614 such that an inner diameter of the deployment catheter 614is available for passage of other devices. The output of crimpingcreates a capsule encompassing the transvalvular bridge 500. Thetransvalvular bridge 500 can be deployed with the use of the dilator616. The transvalvular bridge 500 can be unsheathed from the deploymentcatheter 614. The transvalvular bridge 500 can be deployed such as byunrolling the transvalvular bridge 500. Referring to FIG. 65A, thedilator 616 can move the transvalvular bridge 500 toward the annulus.The dilator 616 can maintain the position of the one or more sutures 654relative to the transvalvular bridge 500. The dilator 616 can functionto allow for suture management. The dilator 616 can function to cinchthe sutures 654. The dilator 616 can also function to cinch thetransvalvular bridge 500.

Referring to FIG. 65B, the deployment catheter 614 can be moved awayfrom the transvalvular bridge 500. The dilator 616 can be partiallywithdrawn into the deployment catheter 614. The deployment catheter 614can include a plurality of pushers 622. Each pusher 622 can include alumen 660. In some embodiments, each retainer 612 can include a singlesuture 654. In some embodiments, each retainer 612 can include two ormore sutures 654. Prior to delivery of the transvalvular bridge 500,each suture 654 can be passed through a lumen 660 of the pusher 622. Thepusher 622 can extend along a length of the suture 654. The deploymentcatheter 614 can include the one or more pushers 622. In the illustratedembodiment, the dilator 616 can include four pushers 622 for the foursutures 654. The number of pushers 622 can correspond to the number ofretainers 612 deployed. The number of pushers 622 can correspond to thenumber of sutures 654 deployed.

Referring to FIG. 65C, the pusher 622 can be moved toward thetransvalvular bridge 500. In some methods of use, two or more pusher 622can move simultaneously. In some methods of use, one or more pushers 622are moved independently of another pusher 622. The one or more pushers622 are moved toward the transvalvular bridge 500 as shown in FIG. 65D.The pusher 622 can be flexible to be deflected outward when moved towardthe transvalvular bridge 500. The pusher 622 can follow the path of thesuture 654 disposed within the lumen 660. As the pusher 622 is movedtoward the transvalvular bridge 500, the suture 654 can be managed. Thesuture 654 can straighten. The suture 654 can be detangled. The pusher622 can cinch the suture 654. The one or more pushers 622 can move thetransvalvular bridge 500 into position. The one or more pushers 622 canmove the transvalvular bridge 500 against the annulus. The one or morepushers 622 can move the transvalvular bridge 500 such that theapertures 508 align with holes created by the needle catheter 610. Theone or more pushers 622 can move the transvalvular bridge 500 such thatthe apertures 508 align with P1, P3, A1, and A3 described herein.

In some embodiments, each suture 654 can include a single clip 620.Prior to delivery of the transvalvular bridge 500, each suture 654 canbe passed through the clip 620. Prior to delivery of the transvalvularbridge 500, each suture 654 can be passed through the clip 620 prior topassing the suture 654 through the lumen 660 of the pusher 622. The clip620 can be disposed on the suture 654. Referring back to FIGS. 65B and65C, the clip 620 can be disposed between the transvalvular bridge 500and the end of the pusher 622. The number of clips 620 can correspond tothe number of sutures 654. In the illustrated embodiment, four clips 620are deployed.

Referring to FIG. 65D, the pusher 622 can advance the clip 620. As thepusher 622 is advanced toward the transvalvular bridge 500, the clip 620can be advanced toward the transvalvular bridge 500. The clip 620 can belocated near a distal end of the pusher 622 as the pusher 622 isadvanced. Referring to FIG. 65E, the clip 620 can be pushed against thetransvalvular bridge 500. The pusher 622 can be withdrawn. FIGS. 65F-65Gshow various other perspective views of deploying the transvalvularbridge 500.

FIGS. 66A and 66B illustrates the clip 620. The clip 620 can include anycross-sectional shape including circular, oval, elliptical or otherrounded configuration. The round edges may reduce trauma to thesurrounding tissue. Other cross-sectional shapes are contemplatedinclude triangular, square, rectangular, or other polygonal shape. Theclip 620 can include a first aperture 662. The first aperture 662 can becircular, oval, elliptical or other rounded configuration.

The clip 620 can include a second aperture 664. The second aperture 664can include a rounded portion 668. The rounded portion 668 can besemi-circular, semi-oval, semi-elliptical or other roundedconfiguration. The rounded portion 668 can be approximately half of acircle. The rounded portion 668 can be approximately half of the secondaperture 664. The second aperture 664 can include a catch portion 670.The catch portion 670 can include a protrusion 672. The protrusion 672can extend inward from the second aperture 664. The protrusion 672 canbe any cross-sectional shape such as triangular, square, rectangular, orother polygonal shape. In the illustrated embodiment, the protrusion 672is triangular. The catch portion 670 can be approximately half of thesecond aperture 664.

The clip 620 can include a third aperture 674. The third aperture 674can include a rounded portion 676. The rounded portion 676 can besemi-circular, semi-oval, semi-elliptical or other roundedconfiguration. The rounded portion 676 can be approximately half of acircle. The rounded portion 676 can be approximately half of the thirdaperture 674. The third aperture 674 can include a catch portion 678.The catch portion 678 can include a protrusion 680. The protrusion 680can extend inward from the third aperture 674. The protrusion 680 can beany cross-sectional shape such as triangular, square, rectangular, orother polygonal shape. In the illustrated embodiment, the protrusion 680is triangular. The catch portion 678 can be approximately half of thethird aperture 674. The second aperture 664 and the third aperture 674can be similar. The second aperture 664 and the third aperture 674 canbe identical. The second aperture 664 and the third aperture 674 can beoriented such that the protrusion 672 of the second aperture 664 iscoaxial with the protrusion 680 of the third aperture 674.

Referring to FIG. 66B, the suture 654 can be passed through the firstaperture 662, the second aperture 664, and the third aperture 674. Thesuture 654 can be passed through the first aperture 662, the secondaperture 664, and the third aperture 674 sequentially. The suture 654can be passed through the first aperture 662, then through the secondaperture 664, and then through the third aperture 674. The suture 654can pass over the clip 620 between the first aperture 662 and the secondaperture 664. The suture 654 can pass under the clip 620 between thesecond aperture 664 and the third aperture 674.

The suture 654 can be passed through the clip 620 in a first direction1D. The suture 654 slides through the first aperture 662. The suture 654slides through the rounded portion 668 of the second aperture 664. Thesuture 654 slides through the rounded portion 676 of the third aperture674. The first direction can move the clip 620 toward the transvalvularbridge 500.

The suture 654 can be limited or prevented from passing through the clip620 in a second direction 2D. As the suture 654 is pulled in the seconddirection, the protrusion 672 of the second aperture 664 can embedwithin the suture 654. As the suture 654 is pulled in the seconddirection, the protrusion 680 of the third aperture 674 can embed withinthe suture 654. The second direction can move the clip 620 away from thetransvalvular bridge 500.

The clip 620 can be a one direction push and lock device. The clip 620can allow travel of the suture 654 through the clip 620 in the firstdirection. The clip 620 can limit travel of the suture 654 through theclip 620 in the second, opposite direction. The clip 620 can bemanufacture from a rigid material such as a metal. In the illustratedembodiment, the clip 620 comprises 316 stainless steel. The clip 620 canhave a high tensile force. The clip 620 can break above the suturestrength. The clip 620 can fit within the deployment catheter 614.

FIGS. 67A and 67B illustrate a handle 684. The handle 684 can be anyshape to facilitate grip by the user. The handle 684 can be designed tofit within the hand of the user. The handle 684 can be designed for useby the right hand, the left hand, or either the left hand or the righthand of the user. The handle 684 includes a wheel 686. The wheel 686 canbe actuated by a finger of the hand of the user. The wheel 686 can beactuated by the thumb. As the wheel 686 is turned, the wheel 686 canactuate one or more gears 688 within the handle 684. The gears 688 cancause an action such as the twisting or turning motion of a catheterattached thereto.

Referring to FIG. 67B, the handle 684 can include an insert 690. Theinsert 690 can couple to the handle 684. The insert 690 can couple to acatheter. In some embodiments, the handle 684 can accept two or moreinserts. In some embodiments, the handle 684 can be designed to coupleto two or more catheters. Each catheter described herein can be designedto couple with an insert. The handle 684 can be considered a universalhandle. The handle 684 can couple to each catheter described herein.

Referring to FIG. 67B, the handle 684 is shown in cross-section. Theinsert 690 can include multiple pieces 690A, 690B, 690C, 690D. The piece690A can have a mirror image piece 690C. The piece 690B can have amirror image piece 690D. The insert 690 can include a lumen 692. Thelumen 692 can be formed from the piece 690A and the corresponding mirrorimage piece 690C. The lumen 692 can be formed from the piece 690B andthe corresponding mirror image piece 690D. The lumen 692 can be sized toaccept a catheter therewithin.

FIGS. 68A and 68B illustrate a steerable catheter 800. The steerablecatheter 800 can be used with the handle 684. The steerable catheter 800can be bi-direction. The steerable catheter 800 can move in at least twodirections. The steerable catheter 800 can include a steering wire 802.In the illustrated embodiment, the steerable catheter 800 includes twosteering wires 802. The steering wires 802 can be disposed 180 degreesfrom each other. The steering wire 802 can allow the steerable catheter800 to collapse along steering wire 802. The steering wire 802 can causethe tip to flex or turn. The steerable catheter 800 can turn in twodirections due to the two steering wires 802. Each steering wire 802 caninclude a steering wire attachment 804. The steering wire attachment 804can couple the steering wire 802 to the steerable catheter 800. Thesteerable catheter 800 can include a distal end 806. The distal end 806can be considered steerable. The user can actuate the steering wire 802to cause the distal end 806 to turn.

The steerable catheter 800 can include a dog bone pattern. The steerablecatheter 800 can include a plurality of ribs 808. The rib 808 caninclude two ends and a narrower middle section disposed therebetween.The ribs 808 can enable the steerable catheter 800 to flex. As thesteerable catheter 800 is flexed, the space between adjacent ribs 808becomes smaller. In some embodiments, the narrower middle section of twoadjacent ribs 808 can touch. The design of the ribs 808 can impact theability of the steerable catheter 800 to flex or rotate. The design ofthe ribs 808 can impact the radius of curvature of the steerablecatheter 800.

FIGS. 68C and 68D depict a steerable needle catheter 810. Any of thecatheters described herein can include one or more features of thesteerable catheter 800. The steerable needle catheter 810 can bebi-direction. The steerable needle catheter 810 can move in at least twodirections. The steerable needle catheter 810 can include the steeringwire 802. The steering wire 802 can allow the steerable needle catheter810 to collapse along steering wire 802. The steering wire 802 can causethe tip to flex or turn. The steering wire 802 can be coupled to thesteerable needle catheter 810. The steerable needle catheter 810 caninclude a dog bone pattern. The steerable needle catheter 810 caninclude a plurality of ribs 808.

The steerable needle catheter 810 can include a radius of curvature R.In some embodiments, the steerable needle catheter 810 can allow thesteerable needle catheter 810 to turn up to 180 degrees from thedirection of travel. In some embodiments, the steerable needle catheter810 can turn up to ninety degrees from the direction of travel. The ribs808 can occur along a portion of the length of the steerable needlecatheter 810. The ribs 808 can allow the portion of the steerable needlecatheter 810 to curve. The steerable needle catheter 810 can bebi-directional. The steerable needle catheter 810 can include the singleneedle catheter 658 as described herein. The needle 628 can protrudefrom the sheath 812. The needle 628 can be sharpened. The needle 628 canbe collinear with the steerable needle catheter 810. The energy tip 644can be collinear with the steerable needle catheter 810. The steerableneedle catheter 810 can facilitate immediate deployment. The singleneedle catheter 658 with the needle 628 is shown in FIG. 68E.

FIGS. 69A and 69B illustrate embodiments of a handle 814. The handle 814can be designed to interact with any catheter described herein. Thehandle 814 can be designed to interact with the steerable needlecatheter 810. The handle 814 can be any shape to facilitate grip by theuser. The handle 814 can be designed to fit within the hand of the user.The handle 814 can be designed for use by the right hand, the left hand,or either the left hand or the right hand of the user.

The handle 814 can allow one or more functions. The handle 814 caninclude a user interface 816 to control the sheath 812. The sheath 812can cover any of the catheters described herein. The sheath 812 cancover the needle 628. The handle 810 can include a user interface 818 todeploy. The user interface 818 can deploy any catheter or any cathetercomponent described herein. In some embodiments, the user interface 818can apply a force for the needle 628 to puncture the annulus. In someembodiments, the user interface 818 can apply a force for the energy tip644 to apply energy to the annulus. The handle 818 can include a userinterface 820 to articulate. The user interface 820 can articulate anycatheter or any catheter component described herein. The user interface820 can articulate the steerable needle catheter 810. The user interface820 can cause the steerable needle catheter 810 to turn. Each of theuser interfaces 816, 818, 820 can be a button, slide, wheel, or otherdevice to enable movement as described herein. Each of the userinterfaces 816, 818, 820 can be the same or similar to another userinterface. In the illustrated embodiment, the user interfaces 816, 818,820 are slides. The handle 814 can be durable and ergonomic.

FIG. 70 shows various access locations. The systems and methodsdescribed herein can be used for any access location. The procedureapproach and delivery system can be trans-femoral, trans-femoral andtrans-apical, trans-apical, trans-apical and trans-atrial, trans-atrial,trans-subclavian, trans-subclavian and trans-apical, or any otherapproach known in the art.

Advantages can include any of the following. The systems and methodsdescribed herein can replicate open procedures. The systems and methodsdescribed herein can replicate open procedures related to the placementof the transvalvular bridge 500. The systems and methods describedherein can replicate open procedures end-securement. The systems andmethods described herein can guarantee suture placement. The systems andmethods described herein can show the user, such as a surgeon, thesuture count prior to first knot. The systems and methods describedherein can provide positional identification of the sutures by valvenomenclature. The systems and methods described herein can be used withthe devices described herein. The systems and methods described hereincan be used with the transvalvular bridge 500. The systems and methodsdescribed herein can be conducted on a beating heart. The systems andmethods described herein can be echogenic. The systems and methodsdescribed herein can prevent or limit occlusions. The systems andmethods described herein can prevent or limit leaflet damage. Thesystems and methods described herein can prevent or limit chordaedamage. The systems and methods described herein can allow for completebail out until first suture is knotted. The systems and methodsdescribed herein can allow for complete identification and count of allcatheter delivery components. The systems and methods described hereincan allow for complete identification and count of all suture tail cuts.The systems and methods described herein can allow for hydraulic orcompressed air delivery of the one or more needle 628. The systems andmethods described herein can include a flexible pressure vessel andneedles. The systems and methods described herein can include a flexibledeployment of retaining system. The systems and methods described hereincan allow for percutaneous securement by knot or ferrule locking device.The systems and methods described herein can allow for trans-apical andtrans-septal hybrid delivery. The systems and methods described hereincan allow for trans-septal and trans-aortic hybrid delivery.

The systems and methods described herein can have simple designs. One ormore of the needle catheter 610, the deployment catheter 614, and thetrimming catheter 624 can have a simple design. One or more of theneedle catheter 610, the deployment catheter 614, and the trimmingcatheter 624 can include a single lumen. One or more of the needlecatheter 610, the deployment catheter 614, and the trimming catheter 624can include embedded catheter features. The needle catheter 610 caninclude a built in plunger 656. The deployment catheter 614 can includea built in pusher 622.

The method can include the step of inserting a sub-annular retainer 612.The method can include the step of inserting the energy tip 644 throughthe tissue of the heart. In some methods of use, the energy tip 644 isinserted through the annulus. In some methods of use, the energy tip 644is inserted through the anterior leaflet. In some methods of use, theenergy tip 644 is inserted through the posterior leaflet. The method caninclude the step of holding the energy tip 644 in position. The methodcan include the step of guiding the energy tip. The method can includethe step of following the energy tip 644 with the needle catheter 610.The method can include the step of intraluminal deployment of thepledget 652. The pledget 652 can be coupled to the suture 654. Themethod can include the step of cinching the suture 654.

The method can include the step of positioning the mitral device. Themitral device can be any device described herein. In some methods ofuse, the method can include the step of positioning transvalvular bridge500. The method can include the step of sliding the transvalvular bridge500 out of the deployment catheter 614. The deployment catheter 614 canbe a single lumen catheter. The method can include the step ofparachuting the transvalvular bridge 500 down with the dilator 616. Themethod can include the step of moving the transvalvular bridge 500toward the annulus. The method can include the step of cinching thesuture 654.

The method can include the step of securely clipping the mitral device.The method can include the step of deploying the clip 620. The methodcan include the step of moving the clip 620 with a pusher 622. Themethod can include the step of securing the clip 620. The clip 620 canbe a self-locking clip. The method can include the step of trimming thesuture 654.

FIGS. 71-73 illustrates the transvalvular bridge 500 positioned withinthe heart. The transvalvular bridge 500 can include the first attachmentstructure 504 at a first end of the bridge 500 and the second attachmentstructure 526 at a second end of the bridge 500. The transvalvular band500 serves both surgical and interventional markets. The sametransvalvular band 500 can be used for both markets. The design of thetransvalvular band 500 is shown in FIGS. 74-76. Systems and methodsincluding tools and transcatheter systems are shown in FIGS. 77-96.

Mitral Regurgitation (MR) occurs when one of the four valves in theheart, the mitral valve, does not close properly, allowing blood to leakbackwards. Mitral Regurgitation is the most common form of valvularheart disease. There are two types of Mitral Regurgitation: FunctionalMitral Regurgitation (FMR) and Degenerative Mitral Regurgitation (DMR).The transvalvular bridge 500 can be used for Functional MitralRegurgitation (FMR). The transvalvular bridge 500 can be used forDegenerative Mitral Regurgitation (DMR). Mitral Regurgitation may leadto shortness of breath and eventually heart failure. MitralRegurgitation affects about 5% of the US population. Some estimatessuggest 2.8M people suffer from Mitral Regurgitation in the US.Approximately 80,000 mitral valve surgeries are performed per year. Someestimates suggest that 41% are in need of intervention. Some estimatessuggest that 41% are in need of intervention, either due to FunctionalMitral Regurgitation (FMR) or Degenerative Mitral Regurgitation (DMR).Some estimates suggest a 5% conversion to percutaneous treatment forMitral Regurgitation. There may be a need for a less invasivetechnology.

For annuloplasty rings, the procedure can be invasive, requiring openheart surgery. The procedure may require cardiopulmonary bypass. Theprocedure may require anticoagulants. There are disadvantages orlimitations to current devices and procedures. The annuloplasty ring maynot be optimal for anatomy. The annuloplasty ring flattens the annulusfrom a natural saddle shape. The annuloplasty ring may affect outcome.The limitations include that the procedure, and subsequent outcome, canbe surgeon technique dependent.

For clips, a guide catheter is inserted through the femoral vein at thegroin and is guided into the mitral valve. The clip delivery systemdelivers and deploys the implant. The clip holds and fastens theleaflets of the valve together. In this procedure, usually two clips aredelivered. There are disadvantages or limitations to current devices andprocedures. The large size of the catheter can be problematic. Theentire length procedure is technically demanding. The long-termdurability of the results of the device is unknown. The device cannot beused in patients with severe pathology of the mitral valve.

The transvalvular band 500 can overcome limitations of other devices.The transvalvular band 500 can be optimal for the anatomy. Thetransvalvular band 500 does not flatten the annulus in some embodiments,but rather conforms to the natural saddle shape. The transvalvular band500 is not surgeon technique dependent in some cases. The shape of thetransvalvular band 500 can be determined prior to surgery, for instanceby selecting the transvalvular band 500 from a plurality of bands. Insome methods of use, the transvalvular band 500 can be implanted in anopen procedure. In some methods of use, the transvalvular band 500 canbe implanted in a minimally invasive procedure. In some methods of use,the transvalvular band 500 can be implemented without cardiopulmonarybypass. In some methods of use, the transvalvular band 500 can beimplemented without anticoagulants. In some methods of use, thetransvalvular band 500 can be implemented with a plurality of anchorlocations. In some methods of use, the transvalvular band 500 can beimplemented with four anchor locations. In some methods of use, thetransvalvular band 500 can be implemented with a plurality of spacedapart anchor locations. In some methods of use, the transvalvular band500 can be implemented with a small, reduced diameter catheter system.In some methods of use, the transvalvular band 500 can be implementedwith a short, non-technically demanding procedure. In some methods ofuse, the transvalvular band 500 can have long-term durability. In somemethods of use, the transvalvular band 500 can be implemented inpatients with severe pathology of the mitral valve. In some methods ofuse, the transvalvular band 500 implantation is simple and effective. Insome methods of use, the transvalvular band 500 implantation is analternative to annuloplasty in mitral valve repair.

The transvalvular band 500 can be a unique technology developed for thetreatment of mitral valve regurgitation. The transvalvular band 500 insome cases can be configured to act as a transannular bridge in theseptolateral dimension. The transvalvular band 500 can be configured toreduce annular dimensions back to normal and physiological needs. Theunique design of the transvalvular band 500 in some embodiments allowsit to be used in either a surgical (open-sternotomy or MIS) ortranscatheter approach.

FIG. 71 illustrates the location of a transvalvular band 500 implantedin the heart. The transvalvular band 500 is positioned to span themitral valve. FIG. 72 illustrates the transvalvular band 500 in theseptolateral dimension. FIG. 73 illustrates the transvalvular band 500illustrates another view of the position of the transvalvular band 500.The position of the transvalvular band 500 avoids the circumflex (Cx)coronary artery. The position of the transvalvular band 500 avoids theatrioventricular (AV) node. The position of the transvalvular band 500avoids the aortic leaflets.

The design of the transvalvular band 500 according to some embodimentsis shown in FIGS. 74-76. The transvalvular bridge 500 can include thefirst attachment structure 504 at a first end of the bridge 500 and thesecond attachment structure 526 at a second end of the bridge 500. Insome embodiments, the first attachment structure 504 is a polyethyleneterephthalate (PET) anchoring pad. In some embodiments, the secondattachment structure 526 is a PET anchoring pad. In some embodiments,the first attachment structure 504 and the second attachment structure526 can be similar or identical in shape. In some embodiments, the firstattachment structure 504 and the second attachment structure 526 can besimilar or identical in material. FIG. 74 shows the bottom view of thetransvalvular band 500. FIG. 75 shows the top or annular view of thetransvalvular band 500. FIG. 76 shows the perspective view of thetransvalvular band 500.

The transvalvular bridge 500 can also include an arcuate central portion502 which can be curved downward. The transvalvular bridge 500 isconcave when implanted. The transvalvular bridge 500 can include aplurality of struts 516. The struts 516 can provide structural supportto the transvalvular bridge 500. In some embodiments, the struts 516form a generally X shape. The arcuate central portion 502 can be formedof silicon. The arcuate central portion 502 can be formed of Nitinol. Insome embodiments, the arcuate central portion 502 can comprise acovering formed silicon with the struts 516 formed of Nitinol. Thetransvalvular bridge 500 can include infra-annular curvature. Thetransvalvular bridge 500 can include a silicon-nitinol bridge betweenthe first and second attachment structures 504, 526. The transvalvularbridge 500 can be a silicone-Nitinol bridge. In some embodiments, thetransvalvular bridge 500 can be a single piece. In some embodiments, thetransvalvular bridge 500 can be multiple pieces coupled together. Insome embodiments, the transvalvular bridge 500 can have no moving parts.

In some embodiments, the transvalvular bridge 500 can be in a pluralityof sizes, for instance, 22 mm, 24 mm, 26 mm, 28 mm, 30 mm, or rangesincorporating any of the foregoing values. Other sizes are contemplatedincluding 10 mm, 12 mm, 14 mm, 16 mm, 18 mm, 20 mm, 21 mm, 23 mm, 25 mm,27 mm, 29 mm, 31 mm, 32 mm, 34 mm, 36 mm, 38 mm, 40 mm, or rangesincorporating any of the foregoing values. In some embodiments, two ormore sizes of the transvalvular bridge 500 are provided. In someembodiments, five sizes of the transvalvular bridge 500 are provided.The transvalvular bridge 500 can include a centered infra-annularcurvature. The transvalvular bridge 500 can be symmetric. Thetransvalvular bridge 500 can have one axis of symmetry. Thetransvalvular bridge 500 can have two axes of symmetry. Thetransvalvular bridge 500 can have three axes of symmetry. Thetransvalvular bridge 500 can have a plurality of axes of symmetry.

The transvalvular bridge 500 can form a continuous infra-annularcurvature. The midpoint or vertex of the transvalvular bridge 500 can becentered. The midpoint or vertex of the transvalvular bridge 500 can becentered between the first and second attachment structures 504, 526.

In some methods of use, the transvalvular bridge 500 reduces thesepto-lateral dimension. In some methods of use, the transvalvularbridge 500 reduces the distance between PPM and leaflet. In some methodsof use, the transvalvular bridge 500 maintains the saddle shape of theannulus. In some methods of use, the transvalvular bridge 500 ensuresearly coaptation of leaflets. In some methods of use, the transvalvularbridge 500 is compliant to annular displacement. In some methods of use,the transvalvular bridge 500 is durable. In some embodiments, thetransvalvular bridge 500 can withstand 400 million cycles. In someembodiments, the transvalvular bridge 500 can withstand 600 millioncycles. In some embodiments, the transvalvular bridge 500 can withstand1 billion cycles. In some embodiments, the transvalvular bridge 500 canwithstand cycles with a displacement of 0.5 mm. In some embodiments, thetransvalvular bridge 500 can withstand cycles with a displacement of−0.5 mm.

FIGS. 77-78 illustrate a transvalvular bridge 500 on a holder 850 with aholding suture 852. The holder 850 can include a flat region designed toabut the transvalvular bridge 500. The holder 850 can span the distancebetween the first and second attachment structures 504, 526. The holdingsuture 852 can couple the transvalvular bridge 500 to the holder 850.The holder 850 can be used to position the transvalvular bridge 500relative to the heart. In some methods of use, removal or release of theholding suture 852 can allow the holder 850 to move away from thetransvalvular bridge 500. In some methods of use, the holding suture 852can extend through the attachment structures 504, 526. In some methodsof use, the holding suture 852 can extend through one or more of theplurality of apertures 508 of the attachment structures 504, 526.

FIG. 77-83 illustrate an open procedure. FIG. 77 illustrates theposition of the transvalvular bridge 500 on a holder 850. FIG. 78-79illustrates the surgeon positioning the transvalvular bridge 500. Theholder 850 facilitates placement of the transvalvular bridge 500. Insome methods of use, the tissue is retracted to provide access to themitral valve. FIG. 80 illustrates the position of the sutures 654 orother sutures described herein extending from the transvalvular bridge500. As described herein, the retainer 612 can be loaded into the needle628. The retainer 612 can include a pledget 652 and the suture 654. FIG.81 illustrates the position of the transvalvular bridge 500 relative tothe mitral valve. The surgeon moves the transvalvular bridge 500 towardthe mitral valve until the transvalvular bridge 500 spans the mitralvalve. The holder 850 can be removed. FIG. 82 illustrates the positionof the transvalvular bridge 500. The transvalvular bridge 500 can besecured by advancing a clip 620. The clip 620 can be pushed along thesuture 654 as described herein. FIG. 83 illustrates the position of thetransvalvular bridge 500 after the transvalvular bridge 500 is secured.

FIGS. 84-86 illustrate a minimally invasive surgical procedure. FIG. 84illustrates a mini thoracotomy. The transvalvular bridge 500 can bedelivered. FIG. 85 illustrates the transvalvular bridge 500 beinginserted into the annulus. FIG. 86 illustrates transvalvular bridge 500anchoring. The surgeon can ensure delivery of the transvalvular bridge500 by viewing a display 854. The display 854 shows the positioning ofthe transvalvular bridge 500 during the minimally invasive surgicalprocedure.

In some methods of use, the transvalvular bridge 500 is placed betweenmidpoints of A2-P2. In some methods of use, the transvalvular bridge 500is placed at the annular level. In some methods of use, the attachmentstructures 504, 526 of the transvalvular bridge 500 are placed levelwith the annulus. In some methods of use, the transvalvular bridge 500is placed with standard sutures. In some methods of use, thetransvalvular bridge 500 is placed with suture 654 as described herein.In some methods of use, the transvalvular bridge 500 has rapidimplantation. In some methods of use, the transvalvular bridge 500 isavailable in a plurality of sizes. In some methods of use, thetransvalvular bridge 500 is in the range of 22 to 30 mm. In some methodsof use, the transvalvular bridge 500 can achieve direct, non-planarseptolateral dimension reduction. In some methods of use, thetransvalvular bridge 500 can restore the annular saddle shape. In somemethods of use, the transvalvular bridge 500 can facilitate preservationof leaflet curvature. In some methods of use, the transvalvular bridge500 can facilitate preservation of annular function. In some methods ofuse, the transvalvular bridge 500 can promotes early coaptation. In somemethods of use, the transvalvular bridge 500 can retrain the leaflet(prolapse) below the annular plane.

In some embodiments, the septolateral dimension is reduced by 10percent. In some embodiments, the septolateral dimension is reduced by15 percent. In some embodiments, the septolateral dimension is reducedby 20 percent. In some embodiments, the septolateral dimension isreduced by 25 percent. In some embodiments, the septolateral dimensionis reduced by 30 percent. In some embodiments, the septolateraldimension is reduced an average of about 25 percent. In someembodiments, the septolateral dimension is reduced about 5 mm. In someembodiments, the septolateral dimension is reduced about 10 mm. In someembodiments, the septolateral dimension is reduced about 15 mm. In someembodiments, the septolateral dimension is reduced about 20 mm. In someembodiments, the septolateral dimension is reduced an average of about10 mm. In some embodiments, the copatation height increases 2 mm. Insome embodiments, the copatation height increases 3 mm. In someembodiments, the copatation height increases 4 mm. In some embodiments,the copatation height increases 5 mm. In some embodiments, thecopatation height increases 6 mm. In some embodiments, the copatationheight increases an average of about 4.5 mm. In some embodiments, themean gradient increase 0.2 mm Hg. In some embodiments, the mean gradientincrease 0.4 mm Hg. In some embodiments, the mean gradient increase 0.6mm Hg. In some embodiments, the mean gradient increase 0.8 mm Hg. Insome embodiments, the mean gradient increase 1.0 mm Hg. In someembodiments, the mean gradient increase an average of about 0.7 mm Hg.In a baseline study, about 60% of patients had moderate-severe mitralregurgitation before implantation. In a baseline study, about 40% ofpatients had—severe mitral regurgitation before implantation. Afterimplantation about 60% of patients had no regurgitation and about 40%had mild regurgitation. Some estimates suggest that over 50% of patientswith annuloplasty rings have moderate or severe regurgitation at twoyears.

The same transvalvular bridge 500 used in open or MIS surgery can bemounted in catheter for trans-septal delivery. The delivery,positioning, and anchoring can be optimized for trans-septal deliveryand implantation.

FIG. 87 illustrates a transcatheter system 900. The transcatheter systemcan deliver the transvalvular bridge 500 or any implant describedherein. The transcatheter system 900 can include any of the features ofthe system of delivery catheters 600 described herein. The transcathetersystem 900 can include any number of primary catheters. In someembodiments, the transcatheter system 900 can include four primarycatheters. The transcatheter system 900 can include a pipeline catheter902. The transcatheter system 900 can include a sheath & needle catheter904. The transcatheter system 900 can include a delivery catheter &suture management catheter 906. The transcatheter system 900 can includea trimming catheter 908.

The transcatheter system 900 can include one or more catheters thatinclude a single lumen. The transcatheter system 900 can include one ormore catheters that include a plurality of lumens. The transcathetersystem 900 can include embedded catheter features. For instance, theclip pushers described herein can be built into the delivery catheter &suture management catheter 906. The transcatheter system 900 can reducecomplexity. The transcatheter system 900 can enable rapid progress andeasy prototypes. The transcatheter system 900 can replicate openprocedure. The transcatheter system 900 can allow delivery while theheart is beating. The transcatheter system 900 can deliver thetransvalvular bridge 500 without cardiopulmonary bypass.

FIG. 88 illustrates the pipeline catheter 902, according to someembodiments. The pipeline catheter 902 can function as a guide and canbe the primary conduit. The pipeline catheter 902 can have any sizeouter diameter and length. In some embodiments, the pipeline catheter902 has an outer diameter of 14 Fr, 16 Fr, 18 Fr, 20 Fr, 22 Fr, 24 Fr,26 Fr, 28 Fr, 30 Fr, 32 Fr, 34 Fr, or ranges incorporating any of theforegoing values, between 20-30 Fr, about 24 Fr, etc. In someembodiments, the pipeline catheter 902 has a length of 70 cm, 80 cm, 90cm, 100 cm, 110 cm, 120 cm, 130 cm, or ranges incorporating any of theforegoing values, between 90-110 cm, about 100 cm, etc. The pipelinecatheter 902 can have a single lumen. The pipeline catheter 902 can besteerable. For instance, a handle of the pipeline catheter 902 cancontrol a flexible tip. The pipeline catheter 902 can be a 90°Bi-directional catheter. The pipeline catheter 902 can be axially stiff.The pipeline catheter 902 can hold a septal position. The pipelinecatheter 902 can be an ultra-flexible dilator. In some embodiments, thepipeline catheter 902 can have a reduced outer diameter during delivery.In some embodiments, the pipeline catheter 902 can have a reduced outerdiameter compared to other delivery catheters.

FIG. 89A illustrates a sheath & needle catheter 904. The sheath & needlecatheter 904 can include a sheath 910 and a needle 912. The sheath 910and the needle 912 are separated in FIG. 89A. FIG. 89B illustrate thedistal end of the sheath & needle catheter 904. The needle 912 isdisposed within the sheath 910 in FIG. 89B. The sheath 910 can have LAsteering. The sheath 910 can have any size outer diameter and length. Insome embodiments, the sheath 910 has an outer diameter of 2 Fr, 4 Fr, 6Fr, 8 Fr, 10 Fr, 12 Fr, 14 Fr, 16 Fr, 18 Fr, 20 Fr, 22 Fr, 24 Fr, orranges incorporating any of the foregoing values, between 10-20 Fr,about 8 Fr, etc. In some embodiments, the sheath 910 has a length of 70cm, 80 cm, 90 cm, 100 cm, 110 cm, 120 cm, 130 cm, or rangesincorporating any of the foregoing values, between 100-120 cm, about 110cm, etc. The sheath 910 can be steerable. The sheath 910 can be a 180°Bi-directional catheter. The sheath 910 can have any bend radius. Insome embodiments, the sheath 910 has bend radius of 8 mm, 8.5 mm, 9 mm,9.5 mm, 10 mm, 10.5 mm, 11 mm, 11.5 mm, 12 mm, 12.5 mm, 13 mm, 13.5 mm,14 mm, 14.5 mm, 15 mm, 15.5 mm, 16 mm, 16.5 mm, 17 mm, or rangesincorporating any of the foregoing values, between 10-15 mm, about 12.5mm, etc.

The needle 912 is designed to be disposed within the sheath 910. Theneedle 912 can include a needle and a needle sheath. The needle 912 canfunction for burn and retainer delivery. In some embodiments, the needle912 has an outer diameter of 1 Fr, 2 Fr, 3 Fr, 4 Fr, 5 Fr, 6 Fr, 7 Fr, 8Fr, 9 Fr, 10 Fr, 12 Fr, 14 Fr, 16 Fr, 18 Fr, 20 Fr, 22 Fr, 24 Fr, orranges incorporating any of the foregoing values, between 1-10 Fr, about5 Fr, etc. In some embodiments, the needle 912 has a length of 70 cm, 80cm, 90 cm, 100 cm, 110 cm, 120 cm, 130 cm, 140 cm, 150 cm, or rangesincorporating any of the foregoing values, between 110-130 cm, about 120cm, etc. The needle 912 can be axially stiff. The needle 912 can be a RFneedle. The needle 912 can be designed to deliver RF energy to burn ahole in the annulus, as described herein. The needle 912 can facilitateflexible pusher deployment. FIG. 89B illustrates the coaxial sheath &needle catheter 904.

FIG. 90A illustrates the delivery catheter & suture management catheter906. The delivery catheter & suture management catheter 906 can functionfor deployment of the transvalvular bridge 500 or any implant describedherein. The delivery catheter & suture management catheter 906 canfunction for suture management and cinching. In some embodiments, thedelivery catheter & suture management catheter 906 has an outer diameterof 1 Fr, 2 Fr, 3 Fr, 4 Fr, 5 Fr, 6 Fr, 7 Fr, 8 Fr, 9 Fr, 10 Fr, 12 Fr,14 Fr, 16 Fr, 18 Fr, 20 Fr, 22 Fr, 24 Fr, or ranges incorporating any ofthe foregoing values, between 1-10 Fr, about 8 Fr, etc. In someembodiments, the delivery catheter & suture management catheter 906 hasa length of 70 cm, 80 cm, 90 cm, 100 cm, 110 cm, 120 cm, 130 cm, 140 cm,150 cm, or ranges incorporating any of the foregoing values, between110-130 cm, about 120 cm, etc. The delivery catheter & suture managementcatheter 906 can be steerable. The delivery catheter & suture managementcatheter 906 can be a 180° Bi-directional catheter. The deliverycatheter & suture management catheter 906 can have any bend radius. Insome embodiments, the sheath 910 has bend radius of 8 mm, 8.5 mm, 9 mm,9.5 mm, 10 mm, 10.5 mm, 11 mm, 11.5 mm, 12 mm, 12.5 mm, 13 mm, 13.5 mm,14 mm, 14.5 mm, 15 mm, 15.5 mm, 16 mm, 16.5 mm, 17 mm, or rangesincorporating any of the foregoing values, between 10-15 mm, about 12.5mm, etc. The delivery catheter & suture management catheter 906 candetangle from each other. The delivery catheter & suture managementcatheter 906 can function to detangle or prevent tangles of the suture654 or any suture described herein. The delivery catheter & suturemanagement catheter 906 can function to be pushable. The deliverycatheter & suture management catheter 906 can push the clips asdescribed herein. FIG. 90B illustrates the distal end of the deliverycatheter & suture management catheter 906. The delivery catheter &suture management catheter 906 can include four ports 914. The number ofports 914 can correspond to the number of apertures 508 of thetransvalvular bridge 500. The number 914 of ports can correspond to thenumber of pushers 622.

FIG. 91 illustrates the sheath & needle catheter 904 with the sheath 910and the needle 912. The needle 912 can include a needle 916 and a needlesheath 918. The needle 916 can be deliver thermal energy, such as RFenergy. The needle 916 can burn a hole through the annulus, as describedherein. The needle 916 can carry a subannular anchor 920. The subannularanchor 920 can anchor the transvalvular bridge 500 or any implantdescribed herein. The subannular anchor 920 can have a star design. Thesubannular anchor 920 can have a holding strength of 10 N, 12 N, 14 N,16 N, 18 N, 20 N, 22 N, 24 N, 26 N, 28 N, 30 N, 32 N, 34 N, 36 N, 38 N,40 N, or ranges incorporating any of the foregoing values, between 15-30N, between 20-26 N, etc. The subannular anchor 920 flattens withtension. The subannular anchor 920 can have a compressed outer diameter.The subannular anchor 920 compressed outer diameter can be 0.2 mm, 0.4mm, 0.6 mm, 0.8 mm, 1.0 mm, 1.2 mm, 1.4 mm, 1.6 mm, 1.8 mm, 2.0 mm. 2.1mm, 2.2 mm, or ranges incorporating any of the foregoing values, between1 mm and 1.5 mm, about 1.2 mm, etc. The subannular anchor 920 can havean expanded diameter. The subannular anchor 920 expanded outer diametercan be 4.5 mm, 5 mm, 5.5 mm, 6 mm, 6.5 mm, 7 mm, 7.5 mm, 8 mm, 8.5 mm, 9mm, or ranges incorporating any of the foregoing values, between 6 mmand 7 mm, about 6.5 mm, etc.

In some embodiments, the subannular anchor 920 can be cylindrical orsubstantially cylindrical when compressed. In some embodiments, thesubannular anchor 920 can have a longer length when compressed or undertension. In some embodiments, the subannular anchor 920 can have apre-formed shaped. In some embodiments, the subannular anchor 920 canassume the pre-formed shaped when the tension is released. In someembodiments, the subannular anchor 920 can assume the pre-formed shapedwhen a constraint is removed. In some embodiments, the subannular anchor920 comprises a shape memory material. In some embodiments, thesubannular anchor 920 comprises Nitinol. In some embodiments, thesubannular anchor 920 can comprise a plurality of struts 922. In someembodiments, the subannular anchor 920 can comprise four struts 922. Insome embodiments, the subannular anchor 920 can comprise equally spacedor unequally spaced struts 922. In some embodiments, the struts 922 canbend outward during expansion.

In some embodiments, the subannular anchor 920 is reversible. Thesubannular anchor 920 can be compressed. The subannular anchor 920 canbe deployed such that the subannular anchor 920 has the expanded outerdiameter. If desired by the surgeon, tension can be applied to thesubannular anchor 920. The subannular anchor 920 can be compressed to asmaller outer diameter. The subannular anchor 920 can be repositionedand redeployed. The subannular anchor 920 facilitates reversibility. Thesubannular anchor 920 can be reversible (e.g., removable) even afterplacement of the transvalvular band 500.

FIG. 92 illustrates deployment of the subannular anchor 920. The needle916 can create holes within tissue. In some methods of use, the needle916 can pass through the apertures 508 of the transvalvular band 500.The needle 916 punctures the underlying tissue. In some methods of use,the needle 916 applies RF energy as described herein. The subannularanchor 920 is passed through the apertures 508 of the transvalvular band500 and the underlying tissue. The subannular anchor 920 can be in acompressed configuration during delivery such that the outer diameter ofthe subannular anchor 920 is reduced. The subannular anchor 920 can becarried by the needle 916 through the annulus. The subannular anchor 920can be deployed. In some methods of use, the subannular anchor 920 isreleased from tension. The struts 922 of the subannular anchor 920expand. The subannular anchor 920 can be positioned on the ventricularside of the annulus. The subannular anchor 920 can be positioned in theleft ventricle. The deployed subannular anchor 920 are shown in FIG. 92.

The subannular anchor 920 can be connected to the suture 654 or othersutures described herein. The clips 620 can be delivered via thedelivery catheter & suture management catheter 906. The clips 620 can bepushed along the suture 654. In some embodiments, the clip 620 can bepushed against the transvalvular band 500. In some embodiments, thesuture 654 can be pulled as the clip 620 is pushed against thetransvalvular band 500. In some embodiments, the suture 654 can bepulled to position the subannular anchor 920 against the tissue. In someembodiments, as the subannular anchor 920 is pulled against the tissuethe subannular anchor 920 flattens horizontally against the tissue. Insome embodiments, as the subannular anchor 920 is pulled against thetissue the subannular anchor 920 embeds in the tissue. FIG. 93illustrates the position of the transvalvular band 500 and the clips620.

FIGS. 94-96 illustrate the transcatheter system 900. FIG. 94 illustratesa fluoroscopic image of the heart. The pipeline catheter 902 or otherguide catheter is through the septal wall. The dilator is across theleft atrium. The Transesophageal Echo (TEE) probe is also shown. FIG.94-96 shows successful deployment of the transvalvular band 500.

FIGS. 97A-97E are views of an embodiment of a transcatheter system 1000.The catheters of transcatheter system 1000 can include any of thefeatures of catheters described herein. FIG. 97A illustrates a guidecatheter 1002. The guide catheter 1002 can provide a transseptal conduitto the left atrium. FIG. 97B illustrates a steering catheter 1004. Insome embodiments, the steering catheter 1004 can be steerable to theannulus. In some embodiments, the steering catheter 1004 can besteerable to the mitral annulus. FIG. 97C illustrates an anchor catheter1006. The anchor catheter 1006 can deliver one or more of the subannularanchor. FIGS. 97A-97C illustrate the three catheters to place theanchors in some embodiments. The three catheters are the guide catheter1002, the steering catheter 1004, and the anchor catheter 1006. FIG. 97Dillusrates a delivery catheter 1008. The delivery catheter 1008 candeliver and secure the transvalvular band 500. The transvalvular band500 can be considered a mitral bridge. FIG. 97E illustrates a trimmingcatheter 1010. The trimming catheter 1010 can cut and secure thesutures. FIGS. 97D-97E illustrates the two catheters to deliver andsecure the transvalvular band 500 in some embodiments. The transcathetersystem 1000 can have the advantage of replicating an open procedure. Thetranscatheter system 1000 can allow for delivery of the transvalvularband 500 to a beating heart. The transcatheter system 1000 can be provento have beating heart delivery success.

The catheters of the transcatheter system 1000 can be utilized in one ormore methods. In some embodiments, the five catheters can be utilized inany number of the following steps. The steps can include 1)transseptally place guide catheter 1002, 2) insert steering catheter1004 with anchor catheter 1006 inside, 3) position the steering catheter1004 and deliver anchors, 4) insert delivery catheter 1008, deploytransvalvular band 500, and cinch, and 5) insert trimming catheter 1010and cut sutures. The method can include transseptal puncture withtransseptal needles. After puncture, the user can transseptally placethe guide catheter 1002. The guide catheter 1002 can provide a conduitto the left atrium. In some embodiments, the user can insert thesteering catheter 1004 through the guide catheter 1002. The steeringcatheter 1004 can be steerable to the annulus. In some embodiments, theanchor catheter 1006 can be disposed inside the steering catheter 1004during positioning of the steering catheter 1004. The user can positionthe steering catheter 1004 and thereby position the anchor catheter1006. The user can deliver four anchors via the anchor catheter 1006.The user can deliver a plurality of anchors sequentially. The user candeliver a plurality of anchors simultaneously. The anchor catheter 1006can deliver the anchors subannularly. The anchor catheter 1006 canpuncture the annulus to deliver the anchor. The user can insert thedelivery catheter 1008. The delivery catheter 1008 can deliver thetransvalvular band 500. The user can deploy the transvalvular band 500,for instance, by unrolling the transvalvular band 500. The transvalvularband 500 can be guided by the sutures extending from the subannularanchors. The delivery catheter 1008 can secure the transvalvular band500. The user can cinch the sutures to position the transvalvular band500. The user can insert the trimming catheter 1010. The user can cutthe sutures via the trimming catheter 1010. The catheters of thetranscatheter system 1000 can be withdrawn.

FIG. 98 illustrates the percutaneous delivery of the transcathetersystem 1000. The transcatheter system 1000 can be inserted in a sequencefor anchor and implant placement. The general transseptal steps caninclude placing an introducer in the right femoral vein. The introducercan be 26 Fr, or any other size to permit access (e.g., 10 Fr, 12 Fr, 14Fr, 16 Fr, 18 Fr, 20 Fr, 22 Fr, 24 Fr, 28 Fr, 30 Fr, 32 Fr, or rangesincorporating any of the foregoing values, between 20-30 Fr, between25-27 Fr, etc.). The general transseptal steps can include transseptalpuncture with a transseptal needle system via right atrium. The generaltransseptal steps can include placing a guidewire through the mitralvalve into the left ventricle. The general transseptal steps can includeremoving transseptal needle system. The general transseptal steps caninclude leaving the guidewire in place.

The method can include anchor placement. The guide catheter 1002, thesteering catheter 1004, and/or the anchor catheter 1006 can be utilizedfor anchor placement. The method can include transseptally placing theguide catheter 1002 over the guidewire. This step can include angling toan appropriate angle such as about 90°. This step can include removing adilator. This step can include removing the guidewire. The method caninclude inserting the steering catheter 1004 into the guide catheter1002. The steering catheter 1004 can include the anchor catheter 1006disposed within the steering catheter 1004. The steering catheter 1004can be advanced through the guide catheter 1002 until the tip of thesteering catheter 1004 can be visualized, such as throughtransesophageal echocardiography (TEE) and/or fluoroscopy. The steeringcatheter 1004 can be advanced beyond the guide catheter 1002. In someembodiments, the steering catheter 1004 can be advanced about 5 cmbeyond the guide catheter 1002. The method can include positioning thesteering catheter 1004 to deliver the anchor catheter 1006. In someembodiments, the anchors are delivered separately. In some embodiments,the steering catheter 1004 can be moved to deliver each anchor. In someembodiments, the anchor catheter 1006 can be moved to deliver eachanchor. The anchor can include features of any anchor described herein.

FIGS. 99-100 are views of subannular anchoring and anchor placementaccording to some embodiments. FIG. 99A illustrates the positions of theannulus. The steering catheter 1004 can be positioned at a desiredlocation, e.g., the 5 o'clock position on annulus. The anchor catheter1006 can be pushed against the annulus. The anchor catheter 1006 caninclude a RF needle, microwave tip, ultrasonic tool, or the like toablate a tissue pathway through the annulus. The anchor catheter 1006can create a passage through the annulus. The anchor catheter 1006 canadvance an anchor subannularly. In some embodiments, the anchor catheter1006 can advance an anchor subannularly about 5-10 mm. Referring to FIG.99B, the anchor catheter 1006 can deploy the anchor 1012. The anchor1012 can be deployed by linearly advancing a pusher. After the anchor isdeployed, the pusher and the RF needle can be withdrawn. The anchorcatheter 1006 can be withdrawn. The anchor catheter 1006 can berepositioned. The steering catheter 1004 can be positioned at the 7o'clock position on annulus. The anchor catheter 1006 can be positionedagainst the annulus and the RF needle can burn through the annulus. Theanchor catheter 1006 can advance an anchor 1012 subannularly and deploythe anchor 1012. The pusher, the RF needle can be withdrawn from the 7o'clock position. The steering catheter 1004 can positioned at the 11o'clock position on annulus. The anchor catheter 1006 can positionedagainst the annulus and the RF needle can create a hole through theannulus. The anchor catheter 1006 can advance an anchor 1012subannularly and deploy the anchor 1012. The pusher, the RF needle canbe withdrawn from the 11 o'clock position. The steering catheter 1004can positioned at the 1 o'clock position on annulus. The anchor catheter1006 can be positioned against the annulus and the RF needle burnsthrough the annulus. The anchor catheter 1006 can advance an anchor 1012subannularly and deploy the anchor 1012. The pusher, the RF needle canbe withdrawn from the 1 o'clock position. The anchors can be deployed inany order. The anchors can be deployed at the 5 o'clock, 7 o'clock, 11o'clock, and 1 o'clock position on the annulus, or other clockpositions. In some embodiments, a first anchor is spaced apart about 180degrees circumferentially on the annulus with respect to a secondanchor, and a third anchor is spaced apart about 180 degreescircumferentially on the annulus with respect to a fourth anchor, eachanchor spaced apart from each other. In some embodiments, a first anchorand a third anchor (and/or a second anchor and a fourth anchor) can bespaced circumferentially about 60 degrees apart, such as between about45 degrees and about 75 degrees apart. Two anchors can be deployed onthe anterior annulus. Two anchors can be deployed on the posteriorannulus. The anchor deployment can be symmetrical. The anchor deploymentcan enable the transvalvular band 500 to span the valve. Other positionsare contemplated, as well as more or less than four anchors.

FIG. 99B illustrates the anchors deployed at the 5 o'clock, 7 o'clock,11 o'clock, and 1 o'clock positions, according to some embodiments. The5 o'clock and 7 o'clock positions can include the posterior anchorsunder the annulus. The 11 o'clock and 1 o'clock positions can includethe anterior anchors under the annulus. In some embodiments, two or moreanchors are delivered simultaneously. In some embodiments, two or moreanchors are delivered sequentially. In some embodiments, four anchorsare delivered. Each anchor 1012 can include a suture 1014, such thatfour anchors 1012 include four sutures 1014. In some methods of use, thefour sutures 1014 can pass outside the body, extracorporeal, through theguide catheter 1002. The sutures 1014 can extend from the anchors 1012and through the transcatheter system 1000. The sutures 1014 can remainoutside of the body of the patient during the procedure. After theanchors 1012 are delivered, the sutures 1014 can be preliminary cinchedfor sizing of the transvalvular band 500. FIGS. 100A-100B illustrateanchor placement according to some embodiments. FIG. 100A illustratestwo deployed sutures 1014 connected to deployed anchors, the steeringcatheter 1004, and the anchor catheter 1006. The deployed sutures 1014can extend through the steering catheter 1004 and outside the body ofthe patient. The anchor catheter 1006 can be in position to deliveranother anchor 1012. FIG. 100B illustrates a deployed anchor 1012,according to some embodiments.

FIG. 101 is a view of preliminary cinching according to someembodiments. The four anchors 1012 can be deployed such that the fourcorresponding sutures extend through the annulus. The sutures can extendfrom the anchor to the steering catheter 1004. According to someembodiments, the sutures 1014 can be cinched together before delivery ofthe transvalvular band 500. In some embodiments, the preliminarycinching can allow for sizing of the transvalvular band 500. FIG. 101 isa view of the left ventricle. In some embodiments, the steering catheter1004 can cinch the sutures 1014 by movement of the steering catheter1004, such as movement toward the annulus.

The method can include delivery of the transvalvular band 500 or anyother implant described herein, according to some embodiments. Thedelivery catheter 1008 and/or the trimming catheter 1010 can be utilizedfor delivery and securing of the transvalvular band 500. The method caninclude any of the following: inserting the delivery catheter 1008,deploying the transvalvular band 500, and cinching. The transvalvularband 500 can be threaded onto the four extracorporeal sutures 1014. Eachsuture 1014 can be threaded through an aperture 508 on the transvalvularband 500. As described herein, the four extracorporeal sutures 1014 canbe coupled to the deployed subannular anchors 1012. Each suture can havea free end which can be threaded through the transvalvular band 500. Insome methods of use, locking clips 1016 can be threaded onto the sutures1014 after the transvalvular band 500 is threaded, such that a lockingclip 1016 can be threaded onto each suture 1014. In some methods of use,the four sutures 1014 can be threaded through the distal end of thedelivery catheter 1008 after the four sutures are threaded through thetransvalvular band 500. The free ends of the four sutures 1014 can bepulled out the proximal end of the delivery catheter 1008. Thetransvalvular band 500 can be loaded into the guide catheter 1002 afterbeing threaded onto the sutures 1014. In some embodiments, thetransvalvular band 500 can be rolled or compressed to fit within theguide catheter 1002. The delivery catheter 1008 can be configured topush the transvalvular band 500 down the lumen of the guide catheter1002. The delivery catheter 1008 can be configured to push thetransvalvular band 500 along the sutures 1014. The delivery catheter1008 can be configured to push the transvalvular band 500 through thedistal end of guide catheter 1002. The delivery catheter 1008 candeliver the transvalvular band 500. In some embodiments, thetransvalvular band 500 can unroll or expand within the heart of thepatient. The transvalvular band 500 can be deployed into the leftatrium. The delivery catheter 1008 can be configured to push thetransvalvular band 500 along the sutures and toward the annulus. Thetransvalvular band 500 can be cinched into position on the annulus. Thetransvalvular band 500 can span the valve from the anterior leaflet tothe posterior leaflet. Each locking clip 1016 can be advanced along thecorresponding suture 1014 by a clip pusher. The locking clips 1016 canbe secured to the transvalvular band 500 by advancing the clip pushers.The transvalvular band 500 can be pushed against the annulus and securedby the locking clips 1016. The delivery catheter 1008 can be removedafter the transvalvular band 500 is secured.

The method can include trimming the sutures 1014 according to someembodiments. The suture 1014 can be fed into the trimming catheter 1010.The trimming catheter 1010 can be inserted into the guide catheter 1002.The trimming catheter 1010 can be advanced to the surface of thetransvalvular band 500 and the locking clip 1016. The trimming catheter1010 can be configured to cut the suture 1014. In some embodiments, thetrimming catheter 1010 can be removed after trimming a suture 1014.Another suture can be fed into the trimming catheter 1010, and thetrimming catheter 1010 can be inserted into the guide catheter 1002. Thetrimming catheter can be advanced toward the transvalvular band 500 andcut the corresponding suture 1014. The sequence can be repeated for allfour sutures 1014. In some embodiments, after the sutures 1014 aretrimmed, the guide catheter 1002 can be removed. The transvalvular band500 can be implanted and secured. FIG. 71 illustrates the transvalvularband 500 with the locking clips securing the transvalvular band 500according to some embodiments.

FIGS. 102A-102D are views of suture threading and insertion of thetransvalvular bridge 500 according to some embodiments. FIG. 102Aillustrates sutures 1014 threaded through the transvalvular band 500according to some embodiments. Each suture 1014 can be threaded throughan aperture 508 of the transvalvular band 500. FIG. 102B illustrates thesutures 1014 threaded into the delivery catheter 1008 according to someembodiments. FIG. 102C illustrates the transvalvular band 500 prior toloading in the guide catheter 1002 according to some embodiments. FIG.102D illustrates pushing the transvalvular band 500 down the guidecatheter 1002 according to some embodiments.

FIGS. 103A-103D are views of the transvalvular band 500 according tosome embodiments. The transvalvular band 500 can be considered a bridge.In some embodiments, the transvalvular band 500 can be rolled to fitwithin the guide catheter 1002. The transvalvular band 500 can be rolledas shown in FIG. 103A. The transvalvular band 500 can be deployed bybeing pushed from the guide catheter 1002 as shown in FIG. 103B-103D.The transvalvular band 500 can fit within the inner diameter of theguide catheter 1002. In some embodiments, the transvalvular band 500 canfit within a 16 Fr inner diameter catheter. Other configurations arecompleted (e.g., fits within catheters of about, less than about, ormore than about 10 Fr inner diameter, 12 Fr inner diameter, 14 Fr innerdiameter, 18 Fr inner diameter, 20 Fr inner diameter, 22 Fr innerdiameter, or ranges incorporating any of the foregoing values etc.). Thetransvalvular band 500 can be resilient to being rolled. In someembodiments, the transvalvular band 500 was tested after deployment,including 5 roll ups and deployment, and 750 million cycles. Thetransvalvular band 500 can be considered durable and showed no signs ofdamage or wear during the aforementioned test.

FIG. 104 is a schematic view of the threading of sutures 1014 accordingto some embodiments. The anchors 1012 can be deployed in situ. Eachanchor 1012 can be connected to a suture 1014. The anchors can be placedsubannularly. In some embodiments, the sutures 1014 can extend throughthe annulus. The sutures 1014 can extend from the anchors 1012 in situand through the guide catheter 1002. The sutures 1014 can extend fromthe guide catheter 1002 and through the transvalvular band 500. Thesutures 1014 can extend from the transvalvular band 500 through thelocking clips 1016. The sutures 1014 can be threaded through thetransvalvular band 500 and the locking clips 1016. The threaded andcrimped transvalvular band 500 can pass through the guide catheter 1002as described herein. The sutures 1014 can extend from the locking clips1016 through the delivery catheter 1008. The sutures 1014 can have freeends extending from the delivery catheter 1008. The sutures 1014 canextend out of the proximal end of the delivery catheter 1008. Thesutures ends can be extracorporeal. The arrows show an example of thesuture threading direction. The suture 1014 can be attached to an anchor1012 which is subannularly placed. The suture 1014 can be passed throughthe guide catheter 1002. The suture 1014 can be threaded through thetransvalvular band 500 and locking clips 1016. The threaded and crimpedtransvalvular band 500 according to some embodiments is shown in FIG.104. The threaded and crimped transvalvular band 500 is sized to fitwithin the guide catheter 1002. The suture 1014 can pass through thedelivery catheter 1008 and out the proximal end of the delivery catheter1008.

FIG. 105 is a schematic view of the trimming of sutures 1014, accordingto some embodiments. The anchors 1012 can be deployed in situ. Eachanchor 1012 can be connected to a suture 1014. The sutures 1014 canextend from anchors 1012, through the transvalvular band 500, andthrough the locking clips 1016. The sutures 1014 can be threaded throughthe transvalvular band 500 and the locking clips 1016. The transvalvularband 500 can be positioned adjacent to the annulus and the locking clips1016 can be secured. The sutures 1014 can extend from the locking clips1016 and through the guide catheter 1002. The sutures 1014 can extendfrom the guide catheter 1002 to the trimming catheter 1010. The trimmingcatheter 1010 can be threaded onto each suture 1014. The suture 1014 isfed into the trimming catheter 1010. The trimming catheter 1010 can beadvanced through the guide catheter 1002. The trimming catheter 1010 canbe moved toward the transvalvular band 500 and locking clips 1016. Thetrimming catheter 1010 can be designed to stop at the surface of thetransvalvular band 500 and locking clips 1016. The trimming catheter1010 can cut the suture 1014. The sequence can be repeated three moretimes until each suture 1014 is trimmed. The red arrows show an exampleof the suture threading direction. The suture 1014 can be attached to ananchor 1012 which is subannularly placed. The suture 1014 can bethreaded through the transvalvular band 500 and locking clips 1016. Thesuture 1014 can be passed through the guide catheter 1002. The suture1014 passes through the trimming catheter 1010. The green arrows showthe direction of the trimming catheter 1010. The suture 1014 is fed intothe trimming catheter 1010. The trimming catheter 1010 can be advancedthrough the guide catheter 1002. The trimming catheter 1010 can stop atthe surface of the transvalvular band 500 and the locking clip 1016. Thetrimming catheter 1010 can cut the suture 1014. The sequence can berepeated.

FIGS. 106A-106E are views of a transcatheter system according to someembodiments. FIG. 106A illustrates the guide catheter 1002 according tosome embodiments. The guide catheter 1002 can have any size outerdiameter and length. The guide catheter 1002 can have a 24 Fr outerdiameter. The guide catheter 1002 can have a 100 cm length. In someembodiments, the guide catheter 1002 has an outer diameter of 14 Fr, 16Fr, 18 Fr, 20 Fr, 22 Fr, 24 Fr, 26 Fr, 28 Fr, 30 Fr, 32 Fr, 34 Fr, orranges incorporating any of the foregoing values, between 20-30 Fr,about 24 Fr, etc. In some embodiments, the guide catheter 1002 has alength of 70 cm, 80 cm, 90 cm, 100 cm, 110 cm, 120 cm, 130 cm, or rangesincorporating any of the foregoing values, between 90-110 cm, about 100cm, etc. The guide catheter 1002 can have a single lumen. The guidecatheter 1002 can be steerable. For instance, a handle of the guidecatheter 1002 can control a flexible tip. The guide catheter 1002 can bea 90° Bi-directional catheter.

FIGS. 106B-106C illustrates the steering catheter 1004 according to someembodiments. The steering catheter 1004 can provide left atriumsteering. The steering catheter 1004 can have any size outer diameterand length. The steering catheter 1004 can have a 12 Fr outer diameter.The steering catheter 1004 can have a 110 cm length. In someembodiments, the steering catheter 1004 has an outer diameter of 2 Fr, 4Fr, 6 Fr, 8 Fr, 10 Fr, 12 Fr, 14 Fr, 16 Fr, 18 Fr, 20 Fr, 22 Fr, 24 Fr,or ranges incorporating any of the foregoing values, between 10-20 Fr,about 8 Fr, etc. In some embodiments, the steering catheter 1004 has alength of 70 cm, 80 cm, 90 cm, 100 cm, 110 cm, 120 cm, 130 cm, or rangesincorporating any of the foregoing values, between 100-120 cm, about 110cm, etc. The steering catheter 1004 can be a 180° Bi-directionalcatheter. The steering catheter 1004 can have any bend radius. Thesteering catheter 1004 can have a 12.5 bend radius. In some embodiments,the steering catheter 1004 can have a bend radius of 8 mm, 8.5 mm, 9 mm,9.5 mm, 10 mm, 10.5 mm, 11 mm, 11.5 mm, 12 mm, 12.5 mm, 13 mm, 13.5 mm,14 mm, 14.5 mm, 15 mm, 15.5 mm, 16 mm, 16.5 mm, 17 mm, or rangesincorporating any of the foregoing values, between 10-15 mm, about 12.5mm, etc.

FIGS. 106B-106C illustrates the anchor catheter 1006 according to someembodiments. The anchor catheter 1006 can be sized to be disposed withinthe steering catheter 1004. The anchor catheter 1006 can have any sizeouter diameter and length. The anchor catheter 1006 can have a 5.3 Frouter diameter. The anchor catheter 1006 can have a 120 cm length. Insome embodiments, the anchor catheter 1006 can have an outer diameter of1 Fr, 2 Fr, 3 Fr, 4 Fr, 5 Fr, 6 Fr, 7 Fr, 8 Fr, 9 Fr, 10 Fr, 12 Fr, 14Fr, 16 Fr, 18 Fr, 20 Fr, 22 Fr, 24 Fr, or ranges incorporating any ofthe foregoing values, between 1-10 Fr, about 5 Fr, etc. In someembodiments, the anchor catheter 1006 can have a length of 70 cm, 80 cm,90 cm, 100 cm, 110 cm, 120 cm, 130 cm, 140 cm, 150 cm, or rangesincorporating any of the foregoing values, between 110-130 cm, about 120cm, etc. The anchor catheter 1006 can be designed to provide a passagein the annulus. The anchor catheter 1006 can be designed to deliver RFenergy to burn a hole in the annulus. The anchor catheter 1006 can bedesigned for anchor delivery through the annulus. The anchor catheter1006 can provide pusher deployment of the anchor. FIG. 106C illustratesthe distal end of the steering catheter 1004 and the anchor catheter1006 according to some embodiments. The anchor 1012 can include a stardesign. The anchor 1012 can include, e.g., between about 10N and about26 N of holding strength. The anchor 1012 can flatten with tension. Theanchor 1012 can be inserted through the annulus in the flattenedconfiguration. The anchor 1012 can be deployed by releasing the tension.FIG. 106C illustrates the steering catheter 1008 with the anchorcatheter 1006 disposed within according to some embodiments. The anchor1012 is shown in the illustrated embodiment in the deployed stateaccording to some embodiments. In the compressed or flattened state, theanchor can have a 1 mm outer diameter. In the expanded or deployedstate, the anchor can have a 6 mm outer diameter. Other configurationsare completed, such as a flattened or compressed state having 0.5 mmouter diameter, 1.5 mm outer diameter, 2 mm outer diameter, 2.5 mm outerdiameter, 3 mm outer diameter, 3.5 mm outer diameter, etc. Otherconfigurations are completed, such as an expanded or deployed statehaving 4.5 mm outer diameter, 5 mm outer diameter, 5.5 mm outerdiameter, 6.5 mm outer diameter, 7 mm outer diameter, 7.5 mm outerdiameter, or ranges incorporating any of the foregoing values, etc. Theanchor catheter 1006 can include an RF needle 1018. The RF needle 1018can be disposed in the center of the anchor 1012. The anchor 1012 candeploy relative to the RF needle 1018. The RF needle 1018 can slide orbe withdrawn relative to the anchor 1012. In some embodiments, theanchor catheter 1006 can include a pusher configured to push the anchor1012 relative to the RF needle 1018. The anchor 1012 can be reversible.The anchor 1012 can transition from the compressed to expanded state,and vice versa. The anchor 1012 can be compressed after placement of thetransvalvular bridge 500. The anchor 1012 can be compressed to removethe anchor 1012. The anchor 1012 can be compressed to remove thetransvalvular bridge 500.

FIG. 106D illustrates a delivery catheter 1008 according to someembodiments. The delivery catheter 1008 can function for deployment ofthe transvalvular bridge 500 or any implant described herein. Thedelivery catheter 1008 can function for suture management and/orcinching. The delivery catheter 1008 can have any size outer diameterand length. The delivery catheter 1008 can have a 12 Fr outer diameter.The delivery catheter 1008 can have a 120 cm length. In someembodiments, the delivery catheter 1008 has an outer diameter of 1 Fr, 2Fr, 3 Fr, 4 Fr, 5 Fr, 6 Fr, 7 Fr, 8 Fr, 9 Fr, 10 Fr, 12 Fr, 14 Fr, 16Fr, 18 Fr, 20 Fr, 22 Fr, 24 Fr, or ranges incorporating any of theforegoing values, between 1-10 Fr, about 8 Fr, etc. In some embodiments,the delivery catheter 1008 has a length of 70 cm, 80 cm, 90 cm, 100 cm,110 cm, 120 cm, 130 cm, 140 cm, 150 cm, or ranges incorporating any ofthe foregoing values, between 110-130 cm, about 120 cm, etc. Thedelivery catheter 1008 can be steerable. The delivery catheter 1008 canbe a 180° Bi-directional catheter. The delivery catheter 1008 can haveany bend radius. The delivery catheter 1008 can have a 12.5 bend radius.In some embodiments, the delivery catheter 1008 can have a bend radiusof 8 mm, 8.5 mm, 9 mm, 9.5 mm, 10 mm, 10.5 mm, 11 mm, 11.5 mm, 12 mm,12.5 mm, 13 mm, 13.5 mm, 14 mm, 14.5 mm, 15 mm, 15.5 mm, 16 mm, 16.5 mm,17 mm, or ranges incorporating any of the foregoing values, between10-15 mm, about 12.5 mm, etc. The delivery catheter 1008 can functiondetangle the sutures. The delivery catheter 1008 can function todetangle or prevent tangles of any suture described herein. The deliverycatheter 1008 can include four ports 1020 to manage the sutures 1014,e.g., one port per suture. Each suture 1014 can be threaded through aport 1020 of the delivery catheter 1008. The number of ports 1020 cancorrespond to the number of apertures 508 of the transvalvular bridge500. The number of ports 1020 can correspond to the number of sutures1014. The delivery catheter 1008 can function to push or move one ormore components. The delivery catheter 1008 can push the locking clips1016 toward the transvalvular band 500. The delivery catheter 1008 caninclude one or more pushers to advance the locking clips 1016 toward thetransvalvular band 500 as described herein.

FIG. 106E illustrates the trimming catheter 1010 according to someembodiments. The trimming catheter 1010 can function to cut the sutures1014 to a desired length. The trimming catheter 1010 can have any sizeouter diameter and length. The trimming catheter 1010 can have a 12 Frouter diameter. The trimming catheter 1010 can have a 120 cm length. Insome embodiments, the trimming catheter 1010 has an outer diameter of 1Fr, 2 Fr, 3 Fr, 4 Fr, 5 Fr, 6 Fr, 7 Fr, 8 Fr, 9 Fr, 10 Fr, 12 Fr, 14 Fr,16 Fr, 18 Fr, 20 Fr, 22 Fr, 24 Fr, or ranges incorporating any of theforegoing values, between 1-10 Fr, about 8 Fr, etc. In some embodiments,the trimming catheter 1010 has a length of 70 cm, 80 cm, 90 cm, 100 cm,110 cm, 120 cm, 130 cm, 140 cm, 150 cm, or ranges incorporating any ofthe foregoing values, between 110-130 cm, about 120 cm, etc. Thetrimming catheter 1010 can be guided over a suture 1014. The trimmingcatheter 1010 can pass through the guide catheter 1002. The trimmingcatheter 1010 can provide a repeatable post-cut length of the suture.The trimming catheter 1010 can cut the suture to be approximately 5 to 7mm. Other lengths are contemplated, e.g., 1 mm, 2 mm, 3 mm, 4 mm, 5 mm,6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, orranges incorporating any of the foregoing values, etc. The trimmingcatheter 1010 can include a single cutting port for suture. The trimmingcatheter 1010 can be designed to cut one suture at a time, or aplurality of sutures simultaneously.

FIGS. 107A-107C are views of transseptal access according to someembodiments. FIG. 107A illustrates the general steps of transseptalaccess according to some embodiments. The introducer can be placed inthe right femoral vein or another access point. FIG. 107B illustratestransseptal puncture with a dilator inserted through the atrial septumaccording to some embodiments. FIG. 107C is a view of the posteriorleaflet after transseptal access according to some embodiments.

FIGS. 108A-108C are views of introduction of the transcatheter system1000 according to some embodiments. FIG. 108A illustrate an introduceraccording to some embodiments. As described herein, the introducer canbe a 24 Fr introducer catheter. The guide catheter 1002 can be insertedinto the introducer. FIGS. 108B-108C illustrate the steering catheter1004 and the anchor catheter 1006 according to some embodiments. Theposterior leaflet and the anterior leaflet are also identified.

FIGS. 109A-110B are views of anchor deployment according to someembodiments. FIG. 109A illustrates the guide catheter 1002 and thesteering catheter 1004 according to some embodiments. FIG. 109Billustrates two sutures 1014 deployed according to some embodiments.FIG. 109C illustrates another view of the two deployed sutures 1014,which are coupled to subannular anchors 1012. FIG. 109D illustrates aview of three deployed sutures 1014. The posterior leaflet and theanterior leaflet are also identified. FIG. 110A illustrate the steeringcatheter 1004 and the anchor catheter 1006 according to someembodiments. The deployed sutures 1014 are shown. The anchor catheter1006 is illustrated deploying the last of the four anchors according tosome embodiments. FIG. 110B illustrates another view of the anchor 1012.The aortic valve is shown. The anchor 1012 can be pushed through theannulus after the RF needle creates a passage. The anchor 1012 can be ina compressed state when the anchor 1012 is passed through the annulus.The anchor 1012 can be deployed by releasing the tension on the anchor1012. Other configurations are contemplated such as a shape memorymaterial to deploy the anchor or a mechanical force to deploy theanchor. The enlarged outer diameter of the deployed anchor 1012 canprevent or limit the anchor 1012 from passing back through the annulus.

FIGS. 111A-111C are views of cinching according to some embodiments.FIG. 111A illustrates four deployed sutures 1014 according to someembodiments. The sutures 1014 can be coupled to subannular anchors 1012.FIG. 111B illustrates the steering catheter 1004, the sutures 1014, andthe anchor 1012 connected to one of the sutures 1014. FIG. 111Cillustrates the fully cinched sutures 1014 according to someembodiments. The posterior leaflet and the anterior leaflet are alsoidentified. The aortic valve is shown.

FIG. 112A is a schematic view of transducer positions according to someembodiments. FIG. 112B shows the 3D echo full volume image at onetransducer position. The heart has three planes: the long axis orsagittal plane, the short axis or transverse plane, and the four-chamberor oblique coronal plane. The transducer positions can provide variousviews of the heart.

Advantages can include any of the following related to the placement andcoaxial nature of the one or more catheters. The transcatheter system1000 can provide catheters configured to be disposed within one another.As described herein, the guide catheter 1002 can provide a transseptalconduit to the left atrium. The guide catheter 1002 can have an innerdiameter sized to accept one or more other catheters. For instance, theguide catheter 1002 can accept the steering catheter 1004 therethrough.The guide catheter 1002 can accept the anchor catheter 1006therethrough. In some embodiments, the guide catheter 1002 can acceptthe steering catheter 1004 therethrough, and the steering catheter 1004can accept the anchor catheter 1006 therethrough. In some embodiments,the steering catheter 1004 and the anchor catheter 1006 can be removedafter one or more anchors are installed. In some methods of use, thesteering catheter 1004 and the anchor catheter 1006 can be removed afterfour anchors are installed. The guide catheter 1002 can remain in placeas a transseptal conduit to the left atrium after the steering catheter1004 and the anchor catheter 1006 are removed. The guide catheter 1002can accept the delivery catheter 1008 therethrough. In some embodiments,the delivery catheter 1008 can be removed after the transvalvular band500 is positioned. In some embodiments, the delivery catheter 1008 canbe removed after the transvalvular band 500 is secured by the lockingclips 1016. The guide catheter 1002 can remain in place as a transseptalconduit to the left atrium after the delivery catheter 1008 is removed.The guide catheter 1002 can accept the trimming catheter 1010therethrough. In some embodiments, the trimming catheter 1010 can beremoved after cutting each suture 1014. In some embodiments, thetrimming catheter 1010 can be removed after cutting a plurality ofsutures 1014. The guide catheter 1002 can be removed after the sutures1014 are cut.

Also, advantages can include any of the following related to thefunction of the one or more catheters. The transcatheter system 1000 canprovide the following functions or purposes related to anchor delivery.The guide catheter 1002 can be designed to provide a conduit to the leftatrium. In some embodiments, an introducer and/or dilator can puncturethe atrial septum. The guide catheter 1002 can be positioned to provideaccess to the valve. The steering catheter 1004 can be designed to besteerable to the annulus. The steering catheter 1004 can include a bendradius allowing the tip to position near the annulus. The steeringcatheter 1004 can guide the anchor catheter 1006 to various locations onthe annulus. The steering catheter 1004 can position the anchor catheter1006 at the 5 o'clock position to deliver an anchor 1012. The steeringcatheter 1004 can position the anchor catheter 1006 at the 7 o→clockposition to deliver an anchor 1012. The steering catheter 1004 canposition the anchor catheter 1006 at the 11 o'clock position to deliveran anchor 1012. The steering catheter 1004 can position the anchorcatheter 1006 at the 1 o'clock position to deliver an anchor 1012. Thesteering catheter 1004 can position the anchor catheter 1006 at anyposition on the annulus to deliver an anchor 1012. The steering catheter1004 can position the anchor catheter 1006 at two positions on theposterior leaflet or posterior annulus to deliver two anchors 1012. Thesteering catheter 1004 can position the anchor catheter 1006 at twopositions on the anterior leaflet or anterior annulus to deliver twoanchors 1012. The steering catheter 1004 can position the anchorcatheter 1006 at four positions on the annulus to deliver four anchors1012.

Furthermore, advantages can include any of the following related to thefunction of one or more catheters. The transcatheter system 1000 canprovide the following functions or purposes related to implant delivery.The delivery catheter 1008 can deliver the transvalvular band 500. Thedelivery catheter 1008 can slide the transvalvular band 500 along thesutures 1014 which are attached to the subannular anchors 1012. Theguide catheter 1002 can be sized to accept the transvalvular band 500 ina collapsed configuration. The delivery catheter 1008 can be designed toseparate the four sutures 1014. The delivery catheter 1008 can bedesigned to limit or prevent tangles of the sutures 1014 within theguide catheter 1002. The delivery catheter 1008 can be designed tofacilitate sliding of the transvalvular band 500 along the sutures 1014.The delivery catheter 1008 can be designed to facilitate sliding of thetransvalvular band 500 along the sutures 1014 and toward the annulus.The delivery catheter 1008 can be designed to facilitate sliding of thelocking clips 1016 toward the transvalvular band 500 along the sutures1014. The delivery catheter 1008 can be designed to accommodate a clippusher on each suture 1014 to push the locking clip 1016 along thesuture 1014. The delivery catheter 1008 can be designed to position thetransvalvular band 500 relative to the annulus. The delivery catheter1008 can be designed to secure the transvalvular band 500 relative tothe annulus. The trimming catheter 1010 can be designed to trim thesutures 1014 after the transvalvular band 500 is secured. The trimmingcatheter 1010 can be designed to trim one suture 1014 at a time. Thetrimming catheter 1010 can be designed to slide along the suture towardthe locking clip 1016 and the transvalvular band 500. The trimmingcatheter 1010 can be designed to cut the suture close or substantiallyclose to the locking clip 1016.

Moreover, advantages can include any of the following related tosurgical technique and procedure management. The transcatheter system1000 can provide an intuitive and easy system to deliver thetransvalvular band 500. Each catheter can be utilized in a step of amethod. In some methods of use, the heart can be accessed via atransseptal puncture with one or more transseptal needles. The firststep, according to some embodiments, can include transseptally placingthe guide catheter 1002. The second step according to some embodiments,can include inserting the steering catheter 1004 with the anchorcatheter 1006 inside. The third step according to some embodiments, caninclude positioning the steering catheter 1004 and delivering theanchors 1012. The fourth step according to some embodiments, can includeinserting the delivery catheter to deploy the transvalvular band 500 andcinch. The fifth step according to some embodiments, can includeinserting the trimming catheter 1010 to cut the sutures 1014.

In some embodiments, advantages can include any of the following relatedto anchor delivery. Each anchor 1012 can be attached to a suture 1014.Each anchor 1012 can be attached to a suture 1014 prior to delivery tothe annulus. The sutures 1014 can be firmly and rigidly attached to theanchors 1012. In some embodiments, the suture 1014 can extend from thedistal end of the anchor 1012 to the proximal end of the anchor 1012. Insome embodiments, the suture 1014 can extend from the distal end of theanchor 1012 and through the anchor catheter 1006. In some embodiments,the anchor catheter 1006 can be designed to deliver a single anchor1012. The anchor catheter 1006 can be designed to manage the suture 1014attached to the single anchor 1012. The suture 1014 can extend from theanchor 1012 to the proximal end of the transcatheter system 1000. Thesuture 1014 can extend from the anchor 1012 to outside the body of thepatient. In some embodiments, the anchor catheter 1006 can be steerable.In some embodiments, the steering catheter 1004 can be designed to steerand position the anchor catheter 1006. In some embodiments, the anchorcatheter 1006 can deliver a second anchor 1012. In some embodiments, theanchor catheter 1006 can deliver all four anchors 1012. In someembodiments, the anchor catheter 1006 can be removed after delivery ofan anchor 1012. In some embodiments, the anchor catheter 1006 can bereloaded with another anchor 1012 after delivery of an anchor 1012. Insome embodiments, a second anchor catheter 1006 can be inserted into thesteering catheter 1004 to deliver the second anchor 1012. The anchorcatheter 1006 can be designed to manage one or more sutures 1014extending therethrough. In some embodiments, the anchor catheter 1006can include one or more channels or grooves to accommodate the suture1014.

Still further, advantages can include any of the following related tothe one or more anchors. The anchor 1012 can have a compressedconfiguration in which the anchor 1012 has a smaller outer diameter. Insome embodiments, the anchor catheter 1006 can apply tension to theanchor 1012 to collapse the anchor 1012. The anchor 1012 can have anexpanded configuration in which the anchor 1012 has a larger outerdiameter. In some embodiments, the anchor catheter 1006 can releasetension to the anchor 1012 to expand the anchor 1012. In someembodiments, the anchor catheter 1006 can remove a constraint on theanchor 1012 to expand the anchor 1012. In some embodiments, the anchorcatheter 1006 is configured to push the anchor 1012 from the distal endof the anchor catheter 1006 to expand the anchor 1012. In someembodiments, the anchor catheter 1006 can include a mechanism to expandthe anchor 1012. The mechanism can move the distal end and the proximalend of the anchor 1012 toward each other. In some embodiments, theanchor 1012 can be reversible. The anchor 1012 can expand and compressand expand again. In some embodiments, the anchor 1012 can beirreversible. The anchor 1012 cannot compresses again after expansion.The transcatheter system 1000 can provide a compact system combining asuture 1014 and an anchor 1012. The suture 1014 and the anchor 1012 canbe rigidly coupled. The suture 1014 and the anchor 1012 can be rigidlycoupled prior to subannular delivery. The suture 1014 and the anchor1012 can be rigidly coupled to withstand anchor deployment. The suture1014 and the anchor 1012 can be rigidly coupled during the life cycle ofthe transvalvular band 500.

Advantages can additionally include any of the following related tosubannular anchoring. In some embodiments, the anchor catheter 1006 caninclude a mechanism to create a passageway in the annulus. In someembodiments, the mechanism can be the RF needle 1018. The RF needle 1018can apply energy to the annulus to burn a hole through the annulus. TheRF needle 1018 can extend through the anchor 1012. The RF needle 1018can be centrally placed. The RF needle 1018 can create a passagewayhaving a diameter equal to the outer diameter of the compressed anchor1012. The RF needle 1018 can create a passageway having a diameterlarger than the outer diameter of the compressed anchor 1012. The RFneedle 1018 can create a passageway having a diameter smaller than theouter diameter of the expanded anchor 1012. Other mechanisms arecontemplated. The mechanism can include a punch. The punch can createthe passageway. The punch can be sharpened or blunt. The mechanism caninclude the application of heat, light, or energy. The number of anchors1012 can correspond to the transvalvular band 500. The transvalvularband 500 can be secured by any number of anchors. In some embodiments,the transvalvular band 500 can be designed to be secured with fouranchors 1012. The user therefore can know the suture count prior tosurgery based on the selected transvalvular band 500.

Also, advantages can include any of the following related to securingthe implant. In some embodiments, the transcatheter system 1000 canprovide knotless securement. The locking clips 1016 can be designed toslide along the suture 1014. The locking clips 1016 can slide aftersubannular anchoring. The locking clips 1016 can slide after thetransvalvular band 500 is deployed. In some embodiments, the lockingclips 1016 can be pushed by clip pushers along the sutures 1014. Theclip pushers can be designed to manage the sutures 1014. Each clippusher can surround a suture 1014 to prevent or limit tangles of thesuture 1014. The transcatheter system 1000 can provide implant deliverythat is reversible. In some embodiments, the transvalvular band 500 canbe removable until the locking clips 1014 are secured. In someembodiments, the anchors 1012 can be removable until the locking clips1014 are secured.

Advantages can further include any of the following related to suturemanagement. The anchor catheter 1006 can be designed to manage theattached suture 1014 during delivery of the anchor 1012. The foursutures 1014 can extend outside of the body after subannular deploymentof the anchors 1012. The transvalvular band 500 can include one or moreapertures 508. The number of apertures 508 can correspond to the numberof sutures 1014. The sutures 1014 can be threaded through the apertures508 as shown in FIG. 102A. In some embodiments, the sutures 1014 can bethreaded through the apertures 508 after subannular anchoring. In someembodiments, the sutures 1014 can be threaded through the apertures 508outside the body of the patient. The sutures 1014 can be threadedthrough the ports 1020 in the delivery catheter 1008. The ports 1020 canbe channels or grooves to facilitate separation of the sutures 1014. Insome embodiments, the sutures 1014 can be threaded through the ports1020 in the delivery catheter 1008 after threading the sutures 1014through the transvalvular band 500. In some embodiments, the sutures1014 can be threaded through the ports 1020 in the delivery catheter1008 after subannular anchoring. In some embodiments, the sutures 1014can be threaded through the ports 1020 in the delivery catheter 1008outside the body of the patient. The delivery catheter 1008 can preventor reduce tangles of the sutures during delivery of the transvalvularband 500. The transvalvular band 500 can slide along the sutures 1014within the guide catheter 1002. The locking clips 1016 can slide alongthe sutures 1014 within the guide catheter 1002. The trimming catheter1010 can slide along each suture 1014 after the transvalvular band 500is positioned and secured. The trimming catheter 1010 can include oneport designed to accept one suture 1014. The trimming catheter 1010 canbe designed to manage the suture 1014 as the trimming catheter 1010slides along the suture 1014. In some embodiments, suture managementrelates to the sutures themselves. In some embodiments, two or moresutures 1014 can be the same or similar. In some embodiments, two orsutures 1014 can be different. The sutures 1014 can include anidentifier (e.g., color, label, markings, etc.) For instance, the suture1014 can include an identifier related to the annular position of theassociated anchor 1012.

In addition, advantages can include any of the following related toimplant delivery including, but not limited to, implant delivery to abeating heart. The transcatheter system 1000 can replicate an openprocedure. The transcatheter system 1000 can be deliveredpercutaneously. The transcatheter system 1000 can be delivered in aminimally invasive manner. The transcatheter system 1000 can be insertedthrough transseptal access. The transcatheter system 1000 can allow forprocesses to be completed outside of the body of the patient. Thesutures 1014 can extend outside of the body of the patient aftersubannular anchoring of the anchors 1012. The transcatheter system 1000can allow for the sutures 1014 to be threaded through the transvalvularband 500 outside of the body of the patient after subannular anchoring.The transcatheter system 1000 can allow for the sutures 1014 to bethreaded through the delivery catheter 1008 outside of the body of thepatient after subannular anchoring. The transcatheter system 1000 canallow for the sutures 1014 to be threaded through the trimming catheter1010 outside of the body of the patient after subannular anchoring. Thetranscatheter system 1000 can allow retrieval of the sutures tailsoutside of the body of the patient after subannular anchoring. The heartvalve can be, for example, a mitral, aortic, tricuspid, or pulmonaryvalve. The heart valve annulus can be, for example, a mitral, aortic,tricuspid, or pulmonary valve annulus. The transcatheter system 1000 canbe utilized in any valve of the human body.

The transcatheter systems and methods include many distinguishingfeatures over the prior art, including but not limited to thosedisclosed herein. In some embodiments, the transvalvular bridge is notor does not include an annuloplasty ring. In some embodiments, thetransvalvular bridge does not comprise an enclosed or ring-like shape.As known in the art, the annuloplasty ring may not be optimal foranatomy. The annuloplasty ring can flatten the annulus from its naturalsaddle shape. Further, for an annuloplasty ring, the procedure, andsubsequent outcome, can be dependent on surgical technique.

In some embodiments, the transvalvular bridge can be an elongatestructure. In some embodiments, the transvalvular bridge can be shapedto span across the valve instead of encircle or partially encircle thevalve. In some embodiments, the transvalvular bridge can be shaped tocinch the valve together. In some embodiments, the transvalvular bridgecan cinch the leaflets toward each other to close the valve. In someembodiments, the transvalvular bridge can be designed to span across theleaflets. The transvalvular bridge can include an elongate body having afirst end, a second end, and a central portion connected to the firstend and the second end. In some embodiments, the central portion canhave a convex arcuate shape which is configured to be displaced downwardfrom the first end and the second end.

In some embodiments, the valve is not replaced. In some embodiments, theleaflets are not replaced or rendered non-functional. In someembodiments, the transvalvular bridge can be considered a leafletsupport, rather than a valve replacement. In some embodiments, thetransvalvular bridge is not designed to keep the valve open. In someembodiments, the transvalvular bridge is not designed to keep theleaflets separated. In some embodiments, the transvalvular bridge canallow for normal coaptation of the leaflets which are supported by thetransvalvular bridge. In some embodiments, the transvalvular bridge canat least partially close or cinch the valve together to increase thecontact between the leaflets.

In some embodiments, the delivery systems and methods can allow optimalplacement of the transvalvular bridge based on guided sutures which areanchored subannularly. In some embodiments, the first end and the secondend can be delivered along sutures to the mitral valve annulus. In someembodiments, the delivery systems and methods can include templates foroptimal spacing between two sutures. In some embodiments, the deliverysystems and methods can include templates for optimal spacing betweenfour sutures. In some embodiments, two anchors can be positioned on theposterior annulus. In some embodiments, the spacing between the twoanchors on the posterior annulus can correspond with the spacing of twoapertures on the first end of the transvalvular bridge. In someembodiments, two anchors can be positioned on the anterior annulus. Insome embodiments, the spacing between the two anchors on the anteriorannulus can correspond with the spacing of two apertures on the secondof the transvalvular bridge. In some embodiments, the systems andmethods can include a guide to position the anchor catheter. In someembodiments, the anchors are delivered sequentially such that the singleanchor catheter is repeatedly positioned at the anchor location. In someembodiments, two or more anchors are delivered simultaneously.

In some embodiments, the suture can extend linearly or substantiallylinearly from the anchor. In some embodiments, the suture can extendlinearly or substantially linearly through the hole or other opening intissue, such as the annulus. In some embodiments, the suture can extendlinearly or substantially linearly through the transvalvular bridge. Insome embodiments, the suture can form a linear path from the anchorpositioned under the annulus and through the transvalvular bridgepositioned over the annulus.

In some embodiments, the transvalvular bridge can be anchored to theannulus. In some embodiments, the transvalvular bridge is not anchoredto the commissures, but rather a non-commissure part of the annulus.However, the implant can be anchored to the commissures in someembodiments. In some embodiments, the transvalvular bridge is notanchored to a natural orifice. In some embodiments, the transvalvularbridge can be anchored via an artificially created orifice in theannulus. In some embodiments, the annulus provides a robust tissue foranchoring. The annulus can be described as a fibrous ring attached tothe posterior and anterior leaflet. The annulus can provide sufficientstrength to prevent the anchors from backing out or tearing through theannulus when tension is applied to the sutures. The annulus can bedescribed as saddle shaped and the annulus can be described as changingshape during the cardiac cycle. In some embodiments, the transvalvularbridge can be shaped to match the saddle shape of the annulus andprovide support during the cardiac cycle.

In some embodiments, the transvalvular bridge can be designed to cinchthe posterior annulus and the anterior annulus. In some embodiments, thetransvalvular bridge can bring the leaflets toward each other. In someembodiments, the transvalvular bridge can cinch the leaflets to providesupport. In some embodiments, the transvalvular bridge can cinch theleaflets to change the shape of the leaflets. In some embodiments, thetransvalvular bridge can cinch the leaflets to encourage more contact atcoaptation points or a larger coaptation zone.

In some embodiments, the transvalvular bridge can be reversiblyanchored. In some embodiments, the subannular anchors can be adapted tobe compressed to be delivered through the hole. In some embodiments, thesubannular anchors can assume a larger diameter shape on the undersideof the annulus. In some embodiments, the subannular anchors can changeconfiguration with the application of tension to the subannular anchors.In some embodiments, each subannular anchor can be retrieved through thehole in the annulus. In some embodiments, each subannular anchor can beretrieved after the sutures are cinched. In some embodiments, eachsubannular anchor can be retrieved after the transvalvular bridge isdeployed. In some embodiments, each subannular anchor can be retrievedafter the locking clips are advanced. In some embodiments, eachsubannular anchor can be retrieved until the sutures are trimmed. Insome embodiments, each subannular anchor can be retrieved after completeimplantation of the transvalvular bridge.

In some embodiments, the sutures connected to subannular anchors canfunction as a guide member for the transvalvular bridge. In someembodiments, the system can include a plurality of guide members,including at least one guide member for each end of the transvalvularbridge. In some embodiments, the system can include two guide membersfor each end of the transvalvular bridge. In some embodiments, thesutures described herein are distinct sutures. In some embodiments, eachsubannular anchor can include only one suture. In some embodiments, thesuture can be threaded through the transvalvular bridge. In someembodiments, the suture can form a straight path through thetransvalvular bridge. In some embodiments, the suture is not woventhrough the transvalvular bridge.

In some embodiments, the suture does not form a U-shaped configuration.In some embodiments, the suture does not include two free ends. In someembodiments, one end of the suture can be fixed to the anchor and oneend of the suture can be free. In some embodiments, the suture does notform a loop. In some embodiments, the suture does not form a loopedportion. In some embodiments, the suture is not stitched through theannulus. In some embodiments, the suture has only one free end. In someembodiments, the suture is connected to the subannular anchor at a fixedend. In some embodiments, the suture can form a single path from theanchor through the body of the patient. In some embodiments, the suturecan form a straight path through the annulus. In some embodiments, thesuture can form a straight path through the hole in the annulus. In someembodiments, the suture has a diameter between about 0.02 mm and about0.8 mm (e.g., 0.02 mm, 0.03 mm, 0.05 mm, 0.07 mm, 0.1 mm, 0.15 mm. 0.2mm, 0.3 mm, 0.35 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, or rangesincorporating any of the foregoing values).

In some embodiments, the procedure can begin with anchoring. In someembodiments, the subannular anchors can be advanced toward the annulusof the valve. In some embodiments, the subannular anchors are notpositioned near the first and second commissures of the valve. In someembodiments, the anchors can be advanced into the left atrium toward theannulus. In some embodiments, the anchors can be advanced from the leftatrium to the left ventricle, through the annulus. In some embodiments,the anchors are not advanced from the left ventricle toward the leftatrium.

In some embodiments, a hole can be created in the annulus to pass thecompressed anchor therethrough. In some embodiments, the hole can becreated with the application of energy to ablate the annulus. In someembodiments, the hole can include smooth edges. In some embodiments, thehole can be stretched/dilated to accept a larger diameter cathetertherethrough. In some embodiments, the method of creating the hole canprevent tearing of the annulus. In some embodiments, the hole can be asmaller diameter than the anchor catheter. In some embodiments, theanchor catheter can include features such as a tapper or dilator whichincreases the diameter of the hole, or is not configured to dilate theaperture. In some embodiments, the anchor catheter can reversiblystretch the hole to allow delivery of the anchor. In some embodiments,the hole can retain its original diameter when the anchor catheter isremoved. In some embodiments, the deployed anchor can have a largerdiameter than the hole. In some embodiments, the deployed anchor canhave a cross-section which is larger than the hole (e.g., twice thediameter, three times the diameter, four times the diameter, five timesthe diameter, or ranges incorporating any of the foregoing values).

In some embodiments, the subannular anchor, or a surface thereof canrest against the underside of the annulus. In some embodiments, thesubannular anchor can maintain its position against the underside of theannulus while the suture is cinched. In some embodiments, the system caninclude four anchors. In some embodiments, the system can include twoanchors on the posterior annulus and two anchors on the anteriorannulus. In some embodiments, the suture can pass through the annulusonly once. In some embodiments, the suture is not looped through theannulus in a sewing pattern. In some embodiments, the subannular anchorcan be expanded on the ventricular side of the annulus. In someembodiments, the suture can extend from the ventricular side of annulusand through the hole in the annulus. In some embodiments, the holes andsutures can be in a one-to-one correspondence. In some embodiments, eachsuture can have a separate hole through the annulus. In someembodiments, the suture can extend to the atrial side of the annulus. Insome embodiments, the sutures can be flexible. In some embodiments, thesutures can be pulled taut to be semi-rigid. In some embodiments, thesemi-rigid sutures can provide a guide for the advancement of thedelivery catheter along the sutures. In some embodiments, the semi-rigidsutures can provide a guide for advancement of the transvalvular bridge.In some embodiments, the semi-rigid sutures can provide a guide foradvancement of the locking clips.

In some embodiments, the transvalvular bridge does not includeventricular attachment. In some embodiments, the transvalvular bridgecan extend along the plane of the annulus. In some embodiments, thetransvalvular bridge can be similar to the saddle shape of the valve. Insome embodiments, the convex central portion does not extend beyond thepoint of coaptation or coapatation zone of the leaflets. In someembodiments, the convex central portion does not interfere with naturalcoaptation.

Access to the annulus can be provided in various ways according to someembodiments. In some embodiments, the systems can be advanced throughthe vasculature toward the annulus using any known point of enter to theleft atrium. In some embodiments, the catheters described herein can beintroduced via the femoral vein, to an inferior vena cava, to the rightatrium, and then to the left atrium. The catheters can be deliveredtransseptally. The catheters can be delivered through the fossa ovalis.In some embodiments, the catheters can be introduced via the basilicvein, to the subclavian vein, to the superior vena cava, to the rightatrium, and to the left atrium. In some embodiments, the catheters canbe introduced via the external jugular vein, to the subclavian vein, tothe superior vena cava, to the right atrium, and to the left atrium.Access can be provided by dilators, if needed, according to someembodiments. Access can be provided by one or more sheaths, according tosome embodiments. Access can be provided by one or more steerablecatheters, according to some embodiments. Access can be provided by oneor more catheters or needles configured to puncture the septum to createaccess, according to some embodiments.

In some embodiments, the anchors can be guided into position by theanchor catheter. In some embodiments, the anchor catheter can be guidedinto position by the template catheter. In some embodiments, thetemplate catheter can ensure spacing between the anchors appropriate forthe corresponding band. In some embodiments, the surgeon can positionthe anchor catheter at spaced locations along the annulus. In someembodiments, two anchors can be positioned on the posterior annulus andtwo anchors can be positioned on the anterior annulus. In someembodiments, two anchors can be positioned adjacent to the posteriorleaflet and two anchors can be positioned adjacent to the anteriorleaflet. In some methods, one set of anchors is parallel to another setof anchors.

In some embodiments, the anchors can comprise a shape memory materialsuch as Nitinol or other springy metals. In some embodiments, theanchors can comprise a flexible material allowing the anchors to assumea compressed and expanded shape. In some embodiments, the anchors cancomprise one or more radially expandable prongs that can be reversiblyexpanded and compressed. In some embodiments, the anchors can be coupledand carried by the anchor catheter through the hole in the annulus. Theanchors can be held under tension to assume a compressed shape. Otherconfigurations are contemplated such as a sheath or other constrainingstructure.

In some embodiments, the anchors can be advanced through the hole andpushed distally to the ventricle. In some embodiments, once on theventricular side of the annulus, the anchor catheter can release tensionon the subannular anchor allowing the anchor to expand such that theanchor cannot fit through the hole. In some embodiments, as the tensionis released from the anchors, the anchors can expand. In someembodiments, the struts of the anchors can radially expand andlongitudinally compress. In some embodiments, the anchor can expand to astar shape. The expanded subannular anchor can create a largercross-sectional shape than the hole. The expanded subannular anchor cancreate a larger surface area than the anchors when compressed. In someembodiments, the anchor catheter can retract after placement of theanchor. In some embodiments, the anchors can be reversible. The anchorcan be compressed and pulled back through the hole. In some embodiments,the anchor can compress under the influence of tension and can beextracted through the hole. In some embodiments, the anchor catheter canapply tension to the anchor to compress the anchor.

In some embodiments, the suture can be anchored to the ventricular sideof the annulus. The suture can extend from the subannular anchor andthrough the catheter system. The free end of the suture can be externalto the patient. The extracorporeal sutures can be easily managed. Oncetrimmed, the extracorporeal sutures can be pulled to retrieve thesutures from the left atrium. In some embodiments, the surgeon canretrieve all four sutures and maintain the suture count.

The annulus can provide a robust tissue for anchoring the suture. Thetissue in the area of the annulus can be thicker than other tissues ofthe heart. The tissue can be continuous, without any natural orifices orweaknesses. The anchor can be passed through an artificial hole createdin the annulus. In some embodiments, the hole can be perfectly circular,oval, or other geometries. In some embodiments, the hole can becauterized such as by the application of heat or energy. In someembodiments, the hole can be punched. In some embodiments, the hole canbe created in a way to prevent any areas for stress cracks or tears.

In some embodiments, after placement of the anchors, the transvalvularbridge can advanced toward the annulus. The transvalvular bridge can beadvanced along the sutures after the subannular anchors are expanded.The transvalvular bridge can be pushed distally by one or more guides orby the delivery catheter itself. The transvalvular bridge can beadvanced in a compressed configuration. The transvalvular bridge can berolled to a compressed configuration but still be able to slide alongthe suture. The transvalvular bridge can be expanded within the leftatrium of the heart. The transvalvular bridge can be expanded whenapproaching the annulus. In some embodiments, as the transvalvularbridge is expanded from the delivery catheter, the transvalvular bridgecan assume a pre-set shape. The central portion can curve downward fromthe first end and the second end. The transvalvular bridge can assume aconvex shape. In some embodiments, the transvalvular bridge can beexpanded by removal of a constraint. In some embodiments, thetransvalvular bridge can be expanded by removal of a tubular covering orsheath. In some embodiments, the transvalvular bridge can be expanded bybeing pushed distally.

In some embodiments, the transvalvular bridge can include two or moreapertures for slidable delivery along the sutures. In some embodiments,the transvalvular bridge can be preloaded on the sutures. Themanufacturer can thread the sutures through the transvalvular bridge. Insome embodiments, the surgeon can thread the sutures through theapertures of the transvalvular bridge. The sutures can be threadedthrough the transvalvular bridge outside the body of the patient. Insome embodiments, each suture can correspond to a single aperture in thetransvalvular bridge. In some embodiments, prior to delivery of thetransvalvular bridge, the sutures can be threaded through thetransvalvular bridge such that the transvalvular bridge can slide alongthe sutures toward the annulus. The transvalvular bridge can providesupport to the valve. The transvalvular bridge can be positioned toallow natural coaptation. In some embodiments, the transvalvular bridgedoes not force the valve open. In some embodiments, the transvalvularbridge does not extend into the ventricle. In some embodiments, thetransvalvular bridge does not comprise a stent.

In some embodiments, the locking clips can slide along the sutures. Thelocking clips can be pushed distally toward the annulus. The lockingclips can be designed to be positioned against the transvalvular bridge.In some embodiments, the sutures can allow the surgeon to accuratelyposition the locking clips relative to the transvalvular bridge. In someembodiments, the surgeon can be provided with tactile feedback when thelocking clip is secured by abutting the locking clips against thetransvalvular bridge. The locking clips can be unidirectional to allowdistal movement but prevent proximal movement of the locking clip.

FIGS. 113A-113T are schematic views of methods of use of a transcathetersystem according to some embodiments. The systems and methods canrevolutionize the treatment of mitral or other valve regurgitation. In asimple procedure, surgeons can treat mitral valve regurgitation in vivo,as an alternative to open heart surgery. The catheter system can beintroduced via the femoral vein or other access point and delivered tothe heart. The catheter system can be delivered using a transseptalpuncture. In some embodiments, a guide wire can be positioned to theleft atrium. The guide catheter can be navigated into the heart alongthe guide wire. The guide catheter can gain access to the mitral valve.

FIGS. 113A-113T are views of a transcatheter system 1100 and methods ofuse according to some embodiments. The catheters of transcatheter system1100 can include any of the features of catheters described herein. FIG.113A illustrates a guide catheter 1102. The guide catheter 1102 canprovide a transseptal conduit to, for example, the left atrium. Thetranscatheter system 1100 can include a guide wire 1104. The guide wire1104 can span between the right atrium and the left atrium. The guidewire 1104 can extend from the left atrium, through the valve annulus andtoward the left ventricle. While some embodiments are described in thecontext of a mitral bridge, other implants that span the annulus can beutilized, and the method adapted to other valve annuli including thetricuspid, aortic, and/or pulmonic valve annuli depending on the desiredclinical result.

The guide catheter 1102 can be placed in the left atrium through thetransseptal access. In some embodiments, a template catheter 1106 can beutilized after the guide catheter 1102 is placed. The template catheter1106 can be delivered in a compressed configuration in FIG. 113A. Thetemplate catheter 1106 can be deployed in the left atrium to direct thesystem appropriately to the mitral valve.

FIG. 113B illustrates the template catheter 1106 being deployedaccording to some embodiments. The template catheter 1106 can slidealong the guide wire 1104 toward the mitral valve. The template catheter1106 can include one or more struts 1008. In some embodiments, thenumber of struts 1108 can correspond to the number of anchors, asdescribed herein. The template catheter 1106 can be steered toward themitral valve along the guide wire 1104.

FIG. 113C illustrates the deployed template catheter 1106 according tosome embodiments. The struts 1108 can assume an enlarged cross-section.The struts 1108 can radially expand. The struts 1108 can axiallyshorten. The struts 1108 can fold outward as shown. In some embodiments,each strut can comprise a pair of apertures 1110 through which an anchorcatheter conduit 1112 passes. In the illustrated embodiment, thetemplate catheter 1106 can include four struts 1108 with fourcorresponding anchor catheter conduits 1112. In some embodiments, eachstrut 1108 can support one, two, or more anchor catheter conduit 1112.Other configurations are contemplated (e.g., one strut 1108 supports twoanchor catheter conduits 1112, one strut 1108 supports three anchorcatheter conduits 1112, one strut 1108 supports four anchor catheterconduits 1112, etc.). The anchor catheter conduit 1112 can be a flexibletube. The anchor catheter conduit 1112 can be an enclosed channel orpartially enclosed channel.

FIG. 113D illustrates the deployed template catheter 1106 being movedtoward the mitral valve according to some embodiments. The templatecatheter 1106 can be positioned across the anterior and posteriorleaflets. The template catheter 1106 can provide the appropriate spacingfor the anchors via anchor catheter conduits 1112. The template catheter1106 can be rotated relative to the guide wire 1104 to position theanchor catheter conduits 1112. The anchor catheter conduits 1112 can bepositioned at or near the 5 o'clock, 7 o'clock, 11 o'clock, and 1o'clock positions. In some embodiments, two anchors can be spaced apartfrom another two anchors along an axis of symmetry. The 5 o'clock and 7o'clock positions can be the locations of the anchors on the posteriorannulus. The 11 o'clock and 1 o'clock positions can be the locations ofthe anchors on the anterior annulus. Other positions are contemplated(e.g., 1 o'clock, 2 o'clock, 3 o'clock, 4 o'clock, 5 o'clock, 6 o'clock,7 o'clock, 8 o'clock, 9 o'clock, 10 o'clock, 11 o'clock, 12 o'clock, orany range including two or more values). FIG. 113E illustrates theposition of the template catheter 1106 against the leaflets and theannulus, according to some embodiments. A portion of the templatecatheter 1106 can extend toward the left ventricle and between theleaflets. The struts 1108, or a portion thereof, can be positionedagainst the annulus. The anchor catheter conduits 1112 can extend in anappropriate direction such as downward toward the annulus.

FIG. 113F illustrates an anchor catheter 1116 according to someembodiments. The anchor catheter 1116 can be sized to pass through theanchor catheter conduit 1112 toward the annulus. As described herein,the strut 1108 can include the pair of apertures 1110. The pair ofapertures 1110 can provide a passageway to the annulus. The pair ofapertures 1110 can allow the anchor catheter 1116 to create a hole inthe annulus. The anchor catheter 1116 can be passed through the anchorcatheter conduit 1112 to deliver an anchor subannularly. The anchorcatheter 1116 can use a radio frequency wire system or otherelectromagnetic, mechanical, or other source of energy to ablate a smallpilot hole in the annulus. The anchor catheter 1116 can apply energy tothe annulus as shown in FIG. 113F. In some embodiments, the hole createdby the anchor catheter 116 can be smaller in diameter than the anchorcatheter 1116. In some embodiments, the hole can reversibly stretch toallow passage of the anchor catheter 1116.

FIG. 113G illustrates an anchor catheter 1116 extending through thepilot hole on the ventricular side of the annulus according to someembodiments. The anchor catheter 1116 can carry the anchor 1118 throughthe pilot hole in a compressed configuration. The anchor 1118 can beaxially elongated in the compressed state. The distal tip of the anchorcatheter 1116 can include a wire 1120 used to create the hole. In someembodiments, the anchor catheter 1116 can include a punch to create ahole. FIG. 113H illustrates the deployed anchor 1118 on the ventricularside of the annulus according to some embodiments. The anchor catheter1116 can be retracted through the pilot hole. The anchor 1118 caninclude a tether, such as a suture extending from the anchor 1118. Thesuture 1122 can extend through the anchor catheter 1116. In someembodiments, as the anchor catheter 1116 is retracted, the suture 1122can remain extending from the anchor 1118, through the pilot hole, andto the left atrium as described herein. The suture 1122 can extendthrough the catheter system and extend external to the patient.

FIG. 113I illustrates the plurality of anchors 1118 deployed in asimilar manner according to some embodiments. Four or a different numberof anchors 1118 can be used to secure the mitral bridge. The pluralityof anchors, e.g., four anchors, can be delivered subannularly. In someembodiments, the subannular anchors 1118 can be placed through the pilotholes under the annulus with minimal pressure. In some embodiments, theanchors 1118 can be delivered sequentially such that the anchor catheter1116 can be removed from one anchor catheter conduit 1112 after anchordelivery, and can be inserted into a second anchor catheter conduit 1112for delivery of a second anchor, until all four anchors 1118 aresequentially delivered. In other embodiments, two or more of the anchorscan be delivered simultaneously. FIG. 113I illustrates a portion of thetemplate catheter 1106 extending between the leaflets and along theguide wire 1104 according to some embodiments. In some embodiments, theanchors can be removed after being deployed. The anchors 1118 can becompressed and retrieved from the annulus. The template catheter 1106can be redeployed. The anchor catheter 1116 can create one or moreadditional holes for the subannular anchors.

FIG. 113J shows the four sutures 1122 extending from the four anchors1118 according to some embodiments. In some embodiments, after all fouranchors 1118 are delivered, the template catheter 1106 can be removed.FIG. 113J shows the removal of the template catheter 1106 according tosome embodiments. The template catheter 1106 can be compressed forpassage through the guide catheter 1102. In some embodiments, thetemplate catheter 1106 including the anchor catheter conduit 1112 canprovide suture management. Each suture 1122 can extend through theanchor catheter conduit 1112 such that the sutures 1122 are preventedfrom tangling or tangling is reduced. In some embodiments, the sutures1122 can extend through separate lumens. In some embodiments, thetemplate catheter 1106 can be retracted by sliding along the guide wire1104. In some embodiments, the guide wire 1104 can remain in positionafter the template catheter 1106 is removed.

FIG. 113K illustrates the cinching of the annulus according to someembodiments. FIG. 113L illustrates further cinching of the annulusaccording to some embodiments. In some embodiments, with the anchors1118 in place subannularly and the sutures extending through theannulus, the annulus can be cinched, in other words, the opposing sidesof the annulus can be brought closer together along part of the annulus.The cinching can confirm securement of the subannular anchors 1118. Thecinching can position the anchors 1118 against the annulus. The cinchingcan reduce any slack in the sutures 1122. The cinching can confirm thecorrect mitral bridge size. The cinching can confirm the desired spacingor length between the pair of sutures associated with the posteriorleaflet and the pair of sutures associated with the anterior leaflet.The length of the implant, e.g., mitral bridge, can be selected tomaintain the cinched position of the annulus. In some embodiments, theguide catheter 1102 can be brought toward the annulus to cinch thesutures 1122. In some embodiments, as the guide catheter 1102 movestoward the annulus, the sutures 1122 can be moved toward each other. Insome embodiments, tension is applied to the sutures 1122 to cinch thesutures 1122. The sutures 1122 can be connected to the annulus via thesubannular anchors 1118 in order to move the annulus. The cinching canincrease the engagement between the posterior and anterior leaflet toenhance coaptation, as described herein.

FIG. 113M illustrates the mitral bridge 1130 which can be as describedelsewhere herein and can include any of the features of any implantdescribed herein including a transvalvular band 500. The mitral bridge1130 can be deployed after the anchors are deployed. The mitral bridge1130 can be guided into place through the guide catheter 1102 via thesutures 1122 which are permanently attached to the subannular anchors.The mitral bridge 1130 can include apertures 1132 through which thesutures 1122 can pass. In some embodiments, each aperture 1132 can bedesigned to accept one suture 1122. The first end of the mitral bridge1130 can include two apertures 1132 designed to accept two sutures 1122.The mitral bridge 1130 can be compressed for delivery through the guidecatheter 1102. FIG. 113N illustrates the mitral bridge 1130 deployed inthe left atrium according to some embodiments. The mitral bridge 1130can slide along the anchored sutures 1122 toward the annulus. The secondend of the mitral bridge 1130 can include two apertures 1132 designed toaccept two sutures 1122. The four apertures 1132 can correspond to thefour sutures 1122. The four apertures 1132 can provide suture managementto prevent the sutures 1122 from being tangled during delivery.

FIG. 113O illustrates a delivery catheter 1134 according to someembodiments. The delivery catheter 1134 can move the mitral bridge 1132toward the annulus. Once positioned, the mitral bridge 1130 can be usedin conjunction with the anchored sutures 1122 to cinch the posteriorannulus toward the anterior annulus to facilitate proper leafletcoaptation. The delivery catheter 1134 can move locking clips 1136toward the annulus. Each locking clip 1136 can slide along thecorresponding suture 1122 during delivery. The locking clips 1136 cansecure the mitral bridge 1130. The suture 1122 can be threaded throughthe locking clip 1136 to allow for unidirectional movement. The lockingclip 1136 can allow movement of the locking clip 1136 toward the annulusbut prevent or limit movement of the locking clip 1136 away from theannulus. In some embodiments, the mitral bridge 1130 and the lockingclips 1136 can be simultaneously delivered. In some embodiments, themitral bridge 1130 can be delivered first and the locking clips 1136 canbe delivered after. In some embodiments, the locking clips 1136 can besequentially delivered. The delivery catheter 1134 can be removed asshown in FIG. 113P according to some embodiments.

FIG. 113Q illustrates the deployed mitral bridge 1130 according to someembodiments. The mitral bridge 1130 can be sized to maintain theposition of the sutures 1122. The mitral bridge 1130 can be sized tocinch the sutures 1122 and therefore the annulus. FIG. 113R illustratesa trimming catheter 1138 according to some embodiments. The trimmingcatheter 1138 can slide along the suture 1122 toward the annulus. FIG.113R illustrates a trimming catheter 1138 trimming the suture 1122according to some embodiments. FIG. 113R illustrates the deployed mitralbridge 1130 according to some embodiments. In some embodiments, all foursutures 1122 can be sequentially trimmed by the trimming catheter 1138.The trimming catheter 1138 can allow the suture 1128 to be retrieved bypulling the suture from the body of the patient.

In some embodiments, the systems and methods can allow deployment of amitral bridge without open heart surgery. In some embodiments, thesystems and methods can facilitate septal-lateral annular cinching. Insome embodiments, the systems and methods can be used to close dilatedvalves. In some embodiments, the systems and methods can promotecoapation early in the systolic phase. In some embodiments, the systemsand methods can restore the natural biomechanics of the mitral or othervalve. In some embodiments, the systems and methods can promote ahealthy valve saddle shape. In some embodiments, the systems and methodscan promote cardiac muscle alignment.

Any of a wide variety of specific tissue anchor constructions may beutilized in combination with the transvalvular band of the presentinvention. In addition, a variety of features have been described asillustrative in connection with a variety of implementations of theinvention. Any of the features described above, may be recombined withany other of the embodiments disclosed herein, without departing fromthe present invention, as should be apparent to those of skill in theart. In some embodiments, the transvalvular band does not include acomplete or partial annuloplasty ring, stent-valve, or partial orcomplete replacement valve or replacement valve leaflets and/or does notaffect or substantially affect the size and/or shape of the valveannulus when operably attached to the valve annulus.

While the foregoing detailed description has set forth several exemplaryembodiments of the apparatus and methods of the present invention, itshould be understood that the above description is illustrative only andis not limiting of the disclosed invention. It will be appreciated thatthe specific dimensions and configurations disclosed can differ fromthose described above, and that the methods described can be used withinany biological conduit within the body.

Various other modifications, adaptations, and alternative designs are ofcourse possible in light of the above teachings. Therefore, it should beunderstood at this time that within the scope of the appended claims theinvention may be practiced otherwise than as specifically describedherein. It is contemplated that various combinations or subcombinationsof the specific features and aspects of the embodiments disclosed abovemay be made and still fall within one or more of the inventions.Further, the disclosure herein of any particular feature, aspect,method, property, characteristic, quality, attribute, element, or thelike in connection with an embodiment can be used in all otherembodiments set forth herein. Accordingly, it should be understood thatvarious features and aspects of the disclosed embodiments can becombined with or substituted for one another in order to form varyingmodes of the disclosed inventions. Thus, it is intended that the scopeof the present inventions herein disclosed should not be limited by theparticular disclosed embodiments described above. Moreover, while theinvention is susceptible to various modifications, and alternativeforms, specific examples thereof have been shown in the drawings and areherein described in detail. It should be understood, however, that theinvention is not to be limited to the particular forms or methodsdisclosed, but to the contrary, the invention is to cover allmodifications, equivalents, and alternatives falling within the spiritand scope of the various embodiments described and the appended claims.Any methods disclosed herein need not be performed in the order recited.The methods disclosed herein include certain actions taken by apractitioner; however, they can also include any third-party instructionof those actions, either expressly or by implication. For example,actions such as “attaching a transvalvular bridge to the mitral valveannulus” includes “instructing the attaching of a transvalvular bridgeto the mitral valve annulus.” The ranges disclosed herein also encompassany and all overlap, sub-ranges, and combinations thereof. Language suchas “up to,” “at least,” “greater than,” “less than,” “between,” and thelike includes the number recited. Numbers preceded by a term such as“approximately”, “about”, and “substantially” as used herein include therecited numbers (e.g., about 10%=10%), and also represent an amountclose to the stated amount that still performs a desired function orachieves a desired result. For example, the terms “approximately”,“about”, and “substantially” may refer to an amount that is within lessthan 10% of, within less than 5% of, within less than 1% of, within lessthan 0.1% of, and within less than 0.01% of the stated amount.

1. A system for delivering and anchoring an implant to a valve annulus,the system comprising: an anchor catheter configured to deliver asubannular anchor to a valve annulus of a heart of a patient, the anchorcatheter comprising a portion configured to create a hole in the valveannulus through which the anchor catheter delivers the subannularanchor, wherein the subannular anchor comprises a first configuration inwhich the subannular anchor has a low profile to be delivered throughthe hole and a second configuration in which the subannular anchor isexpanded, wherein the subannular anchor comprises a suture; and atransvalvular band configured to be delivered by sliding thetransvalvular band along the suture toward the valve annulus, whereinthe transvalvular band includes a first anchoring portion and whereinthe suture is configured to extend through the first anchoring portion.2. The system of claim 1, further comprising a locking clip configuredto be delivered by sliding the locking clip along the suture toward thevalve annulus.
 3. The system of claim 1, wherein the anchor catheter isconfigured to deliver a plurality of subannular anchors.
 4. The systemof claim 1, wherein the anchor catheter is configured to deliver foursubannular anchors.
 5. The system of claim 1, wherein the anchorcatheter is configured to deliver two subannular anchors on eachleaflet.
 6. The system of claim 1, wherein the subannular anchor has astar configuration in which a plurality of prongs fold outward.
 7. Thesystem of claim 1, wherein the subannular anchor compresses withtension, wherein the anchor catheter applies tension to compress thesubannular anchor in the first configuration.
 8. The system of claim 1,wherein the transvalvular band comprises the first anchoring portion anda second anchoring portion, and a central portion therebetween, whereinthe central portion comprises a convex arcuate shape and comprises aplurality of crossing struts encapsulated by a material.
 9. The systemof claim 1, wherein the transvalvular band comprises the first anchoringportion and a second anchoring portion, and a central portiontherebetween, wherein each anchoring portion is configured to acceptsutures connected to subannular anchors therethrough.
 10. The system ofclaim 1, further comprising a trimming catheter, wherein the trimmingcatheter is configured to slide along the suture after the transvalvularband is delivered and trim the excess suture.
 11. The system of claim 1,further comprising a catheter configured to allow transseptal access.12. The system of claim 1, wherein at least one catheter is steerable.13. The system of claim 1, further comprising a means for suturemanagement.
 14. The system of claim 1, wherein the anchor catheterfurther comprises a lumen for each suture.
 15. The system of claim 14,wherein the anchor catheter comprises four lumens, each lumen configuredto receive a suture connected to a subannular anchor.
 16. The system ofclaim 1, wherein the anchor catheter comprises a sleeve for each suture.17. The system of claim 1, further comprising four sleeves, each sleeveconfigured to receive a suture connected to a subannular anchor.
 18. Thesystem of claim 1, wherein the anchor catheter is configured to applyenergy to create the hole.
 19. A method for delivering and anchoring animplant to a valve annulus of a valve, the method comprising:percutaneously creating a hole in the valve annulus to deliver asubannular anchor; delivering a subannular anchor through the hole inthe valve annulus in a low profile configuration and expanding thesubannular anchor on the ventricular side of the annulus, wherein thesubannular anchor comprises a suture extending to the upstream side ofthe annulus relative to a direction of blood flow; and delivering atransvalvular band to the valve annulus by sliding the transvalvularband along the suture toward the valve annulus. 20-40. (canceled)
 41. Amethod for treating mitral valve regurgitation, the method comprising:percutaneously delivering a first subannular anchor coupled to a firstsuture, wherein the first suture extends through the annulus;percutaneously delivering a second subannular anchor coupled to a secondsuture, wherein the second suture extends through the annulus; andcinching the first suture and the second suture with a transvalvularimplant. 42-68. (canceled)